Constipation
Conditions
Brief summary
The objective of the study was to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In addition, the effect of treatment on quality of life and general health status was evaluated.
Interventions
DRUGBisacodyl 10 mg
2 x 5 mg bisacodyl once daily
DRUGPlacebo
Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female patients, aged 18 and above 2. Suffering from functional constipation, according to their medical history, as defined by the Rome III diagnostic criteria , i.e.:Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis. 1. Must include 2 or more of the following:: * straining during at least 25% of the defecations * lumpy or hard stools in at least 25% of the defecations * sensation of incomplete evacuation for at least 25% of the defecations * sensation of anorectal obstruction/blockade for at least 25% of the defecations * manual manoeuvres to facilitate at least 25% of the defecations (e.g. digital evacuation, support of the pelvic floor) * fewer than 3 defecations per week 2. Loose stools are rarely present without the use of laxatives 3. There are insufficient criteria for irritable bowel syndrome (IBS) 3. Able and willing to complete a daily e-diary 4. Able and willing to use the trial rescue medication 5. Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation At Visit 2, patients must comply with the following additional inclusion criteria to be eligible for entry into the treatment phase: 6. Functional constipation is confirmed by e-diary data at the end of the baseline period: a. An average of less than 3 CSBMs per week, together with at least one of the following symptoms occurring at least 25% of the time: * straining * incomplete evacuation * lumpy or hard stools (i.e. type 1 or type 2 stools) 7. Compliant with the use of the e-diary throughout the baseline period (compliance is defined as completing 80% of the evening reports) 8. Compliant with the use of rescue medication throughout the baseline period. Compliance is defined as follows: * rescue medication may be used if there has not been a bowel movement for more than 72 hrs rescue medication may not be used on either day -1 or on the day of randomisation (day 1)
Exclusion criteria
1. Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives 2. Patients whose constipation is caused by primary organic disease of the colon or pelvic floor 3. Patients with metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that, in the Investigators opinion, would interfere with participation in the trial 4. Patients with restricted mobility (e.g. wheelchair bound, or bed-ridden) that, in the Investigators opinion, would interfere with participation in the trial 5. Patients with a known hypersensitivity to bisacodyl or any other ingredient in the study medication 6. Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such as acute appendicitis and acute inflammatory bowel diseases), or severe dehydration 7. Patients with anal fissures or ulcerative proctitis with mucosal damage 8. Patients with known clinically significant abnormal electrolyte values 9. Patients whose concomitant therapy includes an opioid medication (e.g. morphine, codeine) 10. Constipation which, in the Investigators opinion, is caused by medication (e.g. anticholinergics) 11. Patients who are not willing to discontinue the use of prohibited concomitant therapy 12. Pre-menopausal women who: 1. are nursing (breast-feeding) or who are pregnant OR 2. who are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include: * transdermal patch * intra-uterine devices/systems (IUDs/IUSs) * oral, implantable or injectable contraceptives * sexual abstinence * sterilisation or a vasectomised partner 13. Participation in another trial with an investigational product with 1 month of enrolment into this study 14. Drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period | 4 Weeks | A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool. The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of CSBMs at Week 2 | Week 2 in treatment period | The number of CSBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. |
| Number of CSBMs at Week 3 | Week 3 in treatment period | The number of CSBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. |
| Number of CSBMs at Week 4 | Week 4 in treatment period | The number of CSBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. |
| Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period | 4 Weeks | A Spontaneous Bowel Movement (SBM) is a non-rescue medication-induced stool. The number of SBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data. |
| Number of SBMs at Week 1 | Week 1 in treatment period | The number of SBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. |
| Number of SBMs at Week 2 | Week 2 in treatment period | The number of SBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. |
| Number of SBMs at Week 3 | Week 3 in treatment period | The number of SBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. |
| Number of SBMs at Week 4 | Week 4 in treatment period | The number of SBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. |
| Time to the First SBM Following the First Dose of Study Medication (SM) | Time of first dose of SM up to 4 weeks | The time to the first SBM following the first dose of SM was captured by the eDiary. The time was censored by the time of intake of rescue medication (RM), the time of premature discontinuation or the end of treatment whatever was minimal. |
| Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline | Baseline and 4 weeks | — |
| Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline | Baseline and week 1 in treatment period | — |
| Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline | Baseline and week 2 in treatment period | — |
| Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline | Baseline and week 3 in treatment period | — |
| Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline | Baseline and week 4 in treatment period | — |
| Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period | 4 weeks | — |
| Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period | 4 weeks | — |
| Number of Premature Withdrawals Over the 4 Weeks Treatment Period | 4 weeks | — |
| Number of Premature Withdrawals at Week 1 in the Treatment Period | Week 1 in the treatment period | — |
| Number of Premature Withdrawals at Week 2 in the Treatment Period | Week 2 in the treatment period | — |
| Number of Premature Withdrawals at Week 3 in the Treatment Period | Week 3 in the treatment period | — |
| Number of Premature Withdrawals at Week 4 in the Treatment Period | Week 4 in the treatment period | — |
| Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period | 4 weeks | — |
| Number of Participants Using Rescue Medication at Week 1 in the Treatment Period | Week 1 in the treatment period | — |
| Number of Participants Using Rescue Medication at Week 2 in the Treatment Period | Week 2 in the treatment period | — |
| Number of Participants Using Rescue Medication at Week 3 in the Treatment Period | Week 3 in the treatment period | — |
| Number of Participants Using Rescue Medication at Week 4 in the Treatment Period | Week 4 in the treatment period | — |
| Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1 | Baseline and week 1 in treatment period | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2 | Baseline and week 2 in treatment period | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3 | Baseline and week 3 in treatment period | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4 | Baseline and week 4 in treatment period | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1 | Baseline and week 1 in treatment period | The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2 | Baseline and week 2 in treatment period | The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3 | Baseline and week 3 in treatment period | The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4 | Baseline and week 4 in treatment period | The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1 | Baseline and week 1 in treatment period | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2 | Baseline and week 2 in treatment period | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3 | Baseline and week 3 in treatment period | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4 | Baseline and week 4 in treatment period | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1 | Baseline and week 1 in treatment period | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2 | Baseline and week 2 in treatment period | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3 | Baseline and week 3 in treatment period | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4 | Baseline and week 4 in treatment period | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1 | Baseline and week 1 in treatment period | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2 | Baseline and week 2 in treatment period | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3 | Baseline and week 3 in treatment period | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4 | Baseline and week 4 in treatment period | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. |
| Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline | Baseline and week 1 in the treatment period | Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline |
| Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline | Baseline and week 2 in the treatment period | Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline |
| Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline | Baseline and week 3 in the treatment period | Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline |
| Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline | Baseline and week 4 in the treatment period | Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline | Baseline and week 1 in the treatment period | Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline | Baseline and week 2 in the treatment period | Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline | Baseline and week 3 in the treatment period | Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline | Baseline and week 4 in the treatment period | Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline | Baseline and week 1 in the treatment period | Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline | Baseline and week 2 in the treatment period | Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline | Baseline and week 3 in the treatment period | Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline | Baseline and week 4 in the treatment period | Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline | Baseline and week 1 in the treatment period | Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline | Baseline and week 2 in the treatment period | Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline | Baseline and week 3 in the treatment period | Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline | Baseline and week 4 in the treatment period | Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline |
| Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator | 4 weeks | Final global assessment scale range: 1 (good) to 4 (bad), ordinal |
| Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient | 4 weeks | Final global assessment scale range: 1 (good) to 4 (bad), ordinal |
| Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator | 4 weeks | Final global assessment scale range: 1 (good) to 4 (bad), ordinal |
| Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient | 4 weeks | Final global assessment scale range: 1 (good) to 4 (bad), ordinal |
| Change From Baseline in the SF-36 Dimension 'Physical Functioning' | Baseline and 4 weeks | The dimension is a sum of 10 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. |
| Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems' | Baseline and 4 weeks | The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. |
| Change From Baseline in the SF-36 Dimension 'Bodily Pain' | Baseline and 4 weeks | The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. |
| Change From Baseline in the SF-36 Dimension 'General Health' | Baseline and 4 weeks | The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. |
| Change From Baseline in the SF-36 Dimension 'Vitality' | Baseline and 4 weeks | The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. |
| Change From Baseline in the SF-36 Dimension 'Social Functioning' | Baseline and 4 weeks | The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. |
| Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems' | Baseline and 4 weeks | The dimension is a sum of 3 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. |
| Change From Baseline in the SF-36 Dimension 'Mental Health' | Baseline and 4 weeks | The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. |
| Number of CSBMs at Week 1 | Week 1 in treatment period | The number of CSBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. |
| Change From Baseline in the SF-36 Physical Component Scale (PCS) | Baseline and 4 weeks | The PCS is a summary scale of the subscales physical functioning, role-physical, bodily pain, and general health. The component scale is norm-based to a standard population. A higher score indicates a better health. |
| Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns' | Baseline and 4 weeks | The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL |
| Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort' | Baseline and 4 weeks | The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL |
| Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort' | Baseline and 4 weeks | The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL |
| Change From Baseline in the PAC-QoL Subscale 'Satisfaction' | Baseline and 4 weeks | The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL |
| Change From Baseline in the PAC-QoL Overall Score | Baseline and 4 weeks | The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL |
| Change From Baseline for Sodium (Normalized Value) | Baseline and 4 weeks | Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range |
| Change From Baseline for Potassium (Normalized Value) | Baseline and 4 weeks | Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range |
| Change From Baseline for Chloride (Normalized Value) | Baseline and 4 weeks | Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range |
| Change From Baseline in the SF-36 Mental Component Scale (MCS) | Baseline and 4 weeks | The MCS is a summary scale of the dimensions vitality, social functioning, role-emotional, and mental health. The component scale is norm-based to a standard population. A higher score indicates a better health. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were partly recruited by commercial research centers and partly by general practitioners.
Pre-assignment details
Participants were randomised into the treatment period only, when functional constipation and compliance with rescue medication were confirmed by eDiary data in the two-weeks baseline period without study medication.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Two bisacodyl-matching 5 mg placebo tablets once daily | 121 |
| Bisacodyl Two bisacodyl 5 mg tablets once daily | 247 |
| Total | 368 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 44 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Protocol Violation | 4 | 10 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Placebo | Bisacodyl | Total |
|---|---|---|---|
| Age, Continuous | 54.7 Years STANDARD_DEVIATION 15.1 | 55.8 Years STANDARD_DEVIATION 15.9 | 55.4 Years STANDARD_DEVIATION 15.6 |
| Baseline assessment regarding the bothersomeness with abdominal bloating A good deal bothersome | 36 Participants | 60 Participants | 96 Participants |
| Baseline assessment regarding the bothersomeness with abdominal bloating A very great deal bothersome | 12 Participants | 47 Participants | 59 Participants |
| Baseline assessment regarding the bothersomeness with abdominal bloating Hardly bothersome | 20 Participants | 33 Participants | 53 Participants |
| Baseline assessment regarding the bothersomeness with abdominal bloating Missing assessment | 1 Participants | 1 Participants | 2 Participants |
| Baseline assessment regarding the bothersomeness with abdominal bloating Moderately bothersome | 40 Participants | 85 Participants | 125 Participants |
| Baseline assessment regarding the bothersomeness with abdominal bloating Not at all bothersome | 12 Participants | 21 Participants | 33 Participants |
| Baseline assessment regarding the bothersomeness with abdominal discomfort A good deal bothersome | 31 Participants | 64 Participants | 95 Participants |
| Baseline assessment regarding the bothersomeness with abdominal discomfort A very great deal bothersome | 6 Participants | 25 Participants | 31 Participants |
| Baseline assessment regarding the bothersomeness with abdominal discomfort Hardly bothersome | 22 Participants | 40 Participants | 62 Participants |
| Baseline assessment regarding the bothersomeness with abdominal discomfort Missing assessment | 1 Participants | 1 Participants | 2 Participants |
| Baseline assessment regarding the bothersomeness with abdominal discomfort Moderately bothersome | 47 Participants | 91 Participants | 138 Participants |
| Baseline assessment regarding the bothersomeness with abdominal discomfort Not at all bothersome | 14 Participants | 26 Participants | 40 Participants |
| Baseline assessment regarding the bothersomeness with constipation A good deal bothersome | 41 Participants | 88 Participants | 129 Participants |
| Baseline assessment regarding the bothersomeness with constipation A very great deal bothersome | 11 Participants | 33 Participants | 44 Participants |
| Baseline assessment regarding the bothersomeness with constipation Hardly bothersome | 5 Participants | 19 Participants | 24 Participants |
| Baseline assessment regarding the bothersomeness with constipation Missing assessment | 1 Participants | 1 Participants | 2 Participants |
| Baseline assessment regarding the bothersomeness with constipation Moderately bothersome | 57 Participants | 91 Participants | 148 Participants |
| Baseline assessment regarding the bothersomeness with constipation Not at all bothersome | 6 Participants | 15 Participants | 21 Participants |
| Baseline assessment regarding the overall satisfaction with bowel habits A good deal satisfied | 3 Participants | 9 Participants | 12 Participants |
| Baseline assessment regarding the overall satisfaction with bowel habits A very great deal satisfied | 3 Participants | 10 Participants | 13 Participants |
| Baseline assessment regarding the overall satisfaction with bowel habits Hardly satisfied | 44 Participants | 93 Participants | 137 Participants |
| Baseline assessment regarding the overall satisfaction with bowel habits Missing assessment | 1 Participants | 1 Participants | 2 Participants |
| Baseline assessment regarding the overall satisfaction with bowel habits Moderately satisfied | 41 Participants | 74 Participants | 115 Participants |
| Baseline assessment regarding the overall satisfaction with bowel habits Not at all satisfied | 29 Participants | 60 Participants | 89 Participants |
| Baseline for dimension 'Bodily pain (BP)' of the SF-36 QoL scale | 68.5 Score on a scale STANDARD_DEVIATION 24.3 | 67.5 Score on a scale STANDARD_DEVIATION 26 | 67.8 Score on a scale STANDARD_DEVIATION 25.4 |
| Baseline for dimension 'General health (GH)' of the SF-36 QoL scale | 68.0 Score on a scale STANDARD_DEVIATION 21.1 | 69.9 Score on a scale STANDARD_DEVIATION 20.6 | 69.3 Score on a scale STANDARD_DEVIATION 20.7 |
| Baseline for dimension 'Mental health (MH)' of the SF-36 QoL scale | 74.2 Score on a scale STANDARD_DEVIATION 18 | 77.0 Score on a scale STANDARD_DEVIATION 16.8 | 76.1 Score on a scale STANDARD_DEVIATION 17.2 |
| Baseline for dimension 'Physical functioning (PF)' of the SF-36v2™ (SF-36) Quality of Life (QoL) | 79.2 Score on a scale STANDARD_DEVIATION 24.3 | 80.1 Score on a scale STANDARD_DEVIATION 24.6 | 79.8 Score on a scale STANDARD_DEVIATION 24.5 |
| Baseline for dimension 'Role limitation due to emotional problems (RE)' of the SF-36 QoL scale | 82.7 Score on a scale STANDARD_DEVIATION 24.7 | 86.3 Score on a scale STANDARD_DEVIATION 22.3 | 85.1 Score on a scale STANDARD_DEVIATION 23.1 |
| Baseline for dimension 'Role limitation due to physical problems (RP)' of the SF-36 QoL scale | 79.7 Score on a scale STANDARD_DEVIATION 25.2 | 80.6 Score on a scale STANDARD_DEVIATION 25.6 | 80.3 Score on a scale STANDARD_DEVIATION 25.5 |
| Baseline for dimension 'Social functioning (SF)' of the SF-36 QoL scale | 83.4 Score on a scale STANDARD_DEVIATION 21.6 | 86.0 Score on a scale STANDARD_DEVIATION 20.9 | 85.1 Score on a scale STANDARD_DEVIATION 21.2 |
| Baseline for dimension 'Vitality (VT)' of the SF-36 QoL scale | 55.7 Score on a scale STANDARD_DEVIATION 20.2 | 58.9 Score on a scale STANDARD_DEVIATION 21 | 57.9 Score on a scale STANDARD_DEVIATION 20.8 |
| Baseline for the Mental Component Scale (MCS) of the SF-36 QoL scale | 49.0 Score on a scale STANDARD_DEVIATION 11 | 51.1 Score on a scale STANDARD_DEVIATION 9.8 | 50.4 Score on a scale STANDARD_DEVIATION 10.3 |
| Baseline for the Physical Component Scale (PCS) of the SF-36 QoL scale | 48.7 Score on a scale STANDARD_DEVIATION 9.4 | 48.3 Score on a scale STANDARD_DEVIATION 9.8 | 48.5 Score on a scale STANDARD_DEVIATION 9.7 |
| Baseline mean score for constipation symptom 'Anorectal obstructions/blockade' | 1.2 Score on a scale STANDARD_DEVIATION 1 | 1.2 Score on a scale STANDARD_DEVIATION 1 | 1.2 Score on a scale STANDARD_DEVIATION 1 |
| Baseline mean score for constipation symptom 'Manual manoeuvre' | 0.2 Score on a scale STANDARD_DEVIATION 0.4 | 0.2 Score on a scale STANDARD_DEVIATION 0.3 | 0.2 Score on a scale STANDARD_DEVIATION 0.3 |
| Baseline mean score for constipation symptom 'Sensation of incomplete evacuation' | 0.7 Score on a scale STANDARD_DEVIATION 0.3 | 0.7 Score on a scale STANDARD_DEVIATION 0.3 | 0.7 Score on a scale STANDARD_DEVIATION 0.3 |
| Baseline mean score for constipation symptom 'Stool quality' | 2.4 Score on a scale STANDARD_DEVIATION 1.2 | 2.5 Score on a scale STANDARD_DEVIATION 1.3 | 2.4 Score on a scale STANDARD_DEVIATION 1.3 |
| Baseline mean score for constipation symptom 'Straining' | 1.9 Score on a scale STANDARD_DEVIATION 0.9 | 1.8 Score on a scale STANDARD_DEVIATION 0.8 | 1.9 Score on a scale STANDARD_DEVIATION 0.8 |
| Baseline number of Complete Spontaneous Bowel Movements (CSBMs) | 1.0 CSBMs per week STANDARD_DEVIATION 1.1 | 1.1 CSBMs per week STANDARD_DEVIATION 1.2 | 1.1 CSBMs per week STANDARD_DEVIATION 1.2 |
| Baseline number of Spontaneous Bowel Movements (SBMs) | 4.2 SBMs per week STANDARD_DEVIATION 2.6 | 4.4 SBMs per week STANDARD_DEVIATION 3.9 | 4.3 SBMs per week STANDARD_DEVIATION 3.6 |
| Baseline overall score (OSC) of PAC-QoL | 1.8 Score on a scale STANDARD_DEVIATION 0.6 | 1.8 Score on a scale STANDARD_DEVIATION 0.7 | 1.8 Score on a scale STANDARD_DEVIATION 0.7 |
| Baseline subscore 'Physical discomfort (PHD)' of PAC-QoL | 1.9 Score on a scale STANDARD_DEVIATION 0.8 | 2.0 Score on a scale STANDARD_DEVIATION 0.9 | 2.0 Score on a scale STANDARD_DEVIATION 0.9 |
| Baseline subscore 'Psychosocial discomfort (PSD)' of PAC-QoL | 0.8 Score on a scale STANDARD_DEVIATION 0.8 | 0.9 Score on a scale STANDARD_DEVIATION 0.8 | 0.9 Score on a scale STANDARD_DEVIATION 0.8 |
| Baseline subscore 'Satisfaction (SAT)' of PAC-QoL | 3.0 Score on a scale STANDARD_DEVIATION 0.7 | 2.8 Score on a scale STANDARD_DEVIATION 0.8 | 2.9 Score on a scale STANDARD_DEVIATION 0.8 |
| Baseline subscore'Worries and concerns (WCC)' of Patient Assessment of Constipation-QoL(PAC-QoL) | 1.4 Score on a scale STANDARD_DEVIATION 0.8 | 1.5 Score on a scale STANDARD_DEVIATION 0.9 | 1.4 Score on a scale STANDARD_DEVIATION 0.9 |
| Baseline value for chloride (normalized value) | 104.0 mmol/L STANDARD_DEVIATION 2.33 | 103.7 mmol/L STANDARD_DEVIATION 2.85 | 103.8 mmol/L STANDARD_DEVIATION 2.69 |
| Baseline value for potassium (normalized value) | 4.2 mmol/L STANDARD_DEVIATION 0.33 | 4.2 mmol/L STANDARD_DEVIATION 0.33 | 4.2 mmol/L STANDARD_DEVIATION 0.33 |
| Baseline value for sodium (normalized value) | 139.5 mmol/L STANDARD_DEVIATION 2.13 | 139.3 mmol/L STANDARD_DEVIATION 2.3 | 139.4 mmol/L STANDARD_DEVIATION 2.24 |
| Sex: Female, Male Female | 96 Participants | 179 Participants | 275 Participants |
| Sex: Female, Male Male | 25 Participants | 68 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 121 | 159 / 247 |
| serious Total, serious adverse events | 2 / 121 | 1 / 247 |
Outcome results
Primary
Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period
A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool. The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.
Time frame: 4 Weeks
Population: Full Analysis Set (FAS): All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period | 1.9 CSBMs per week | Standard Error 0.34 |
| Bisacodyl | Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period | 5.2 CSBMs per week | Standard Error 0.27 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [2.6, 4]ANCOVA
Secondary
Change From Baseline for Chloride (Normalized Value)
Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range
Time frame: Baseline and 4 weeks
Population: Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline for Chloride (Normalized Value) | 0 mmol/L | Standard Deviation 3 |
| Bisacodyl | Change From Baseline for Chloride (Normalized Value) | 0 mmol/L | Standard Deviation 3 |
Secondary
Change From Baseline for Potassium (Normalized Value)
Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range
Time frame: Baseline and 4 weeks
Population: Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline for Potassium (Normalized Value) | 0.0 mmol/L | Standard Deviation 0.3 |
| Bisacodyl | Change From Baseline for Potassium (Normalized Value) | -0.0 mmol/L | Standard Deviation 0.3 |
Secondary
Change From Baseline for Sodium (Normalized Value)
Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range
Time frame: Baseline and 4 weeks
Population: Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline for Sodium (Normalized Value) | -0 mmol/L | Standard Deviation 3 |
| Bisacodyl | Change From Baseline for Sodium (Normalized Value) | -0 mmol/L | Standard Deviation 3 |
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 1 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1 | -0.1 Score on a scale | Standard Error 0.08 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1 | -0.9 Score on a scale | Standard Error 0.06 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-0.9, -0.6]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 2 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2 | -0.1 Score on a scale | Standard Error 0.09 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2 | -0.9 Score on a scale | Standard Error 0.07 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-1, -0.6]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 3 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3 | -0.1 Score on a scale | Standard Error 0.08 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3 | -0.9 Score on a scale | Standard Error 0.07 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-0.9, -0.5]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 4 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4 | -0.1 Score on a scale | Standard Error 0.09 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4 | -0.8 Score on a scale | Standard Error 0.07 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-0.8, -0.5]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 1 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1 | -0.0 Score on a scale | Standard Error 0.03 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1 | -0.2 Score on a scale | Standard Error 0.03 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-0.2, -0.1]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 2 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2 | 0.0 Score on a scale | Standard Error 0.04 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2 | -0.2 Score on a scale | Standard Error 0.03 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-0.3, -0.1]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 3 in treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3 | -0.0 Score on a scale | Standard Error 0.03 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3 | -0.2 Score on a scale | Standard Error 0.03 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-0.2, -0.1]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 4 in treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4 | -0.1 Score on a scale | Standard Error 0.04 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4 | -0.2 Score on a scale | Standard Error 0.03 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.001895% CI: [-0.2, 0]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 1 in treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1 | -0.0 Score on a scale | Standard Error 0.05 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1 | -0.2 Score on a scale | Standard Error 0.04 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.000295% CI: [-0.3, -0.1]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 2 in treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2 | -0.0 Score on a scale | Standard Error 0.05 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2 | -0.2 Score on a scale | Standard Error 0.04 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.000395% CI: [-0.3, -0.1]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 3 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3 | -0.1 Score on a scale | Standard Error 0.05 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3 | -0.2 Score on a scale | Standard Error 0.04 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.012795% CI: [-0.2, 0]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4
The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 4 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4 | -0.1 Score on a scale | Standard Error 0.06 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4 | -0.2 Score on a scale | Standard Error 0.05 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.006495% CI: [-0.3, 0]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1
The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 1 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1 | 0.4 Score on a scale | Standard Error 0.13 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1 | 3.0 Score on a scale | Standard Error 0.11 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [2.4, 2.9]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2
The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 2 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2 | 0.2 Score on a scale | Standard Error 0.15 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2 | 2.7 Score on a scale | Standard Error 0.12 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [2.1, 2.7]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3
The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 3 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3 | 0.5 Score on a scale | Standard Error 0.14 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3 | 2.8 Score on a scale | Standard Error 0.12 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [2, 2.5]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4
The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 4 in treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4 | 0.6 Score on a scale | Standard Error 0.16 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4 | 2.6 Score on a scale | Standard Error 0.13 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [1.7, 2.3]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 1 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1 | -0.3 Score on a scale | Standard Error 0.08 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1 | -1.3 Score on a scale | Standard Error 0.07 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-1.2, -0.9]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 2 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2 | -0.1 Score on a scale | Standard Error 0.09 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2 | -1.1 Score on a scale | Standard Error 0.08 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-1.2, -0.8]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 3 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3 | -0.3 Score on a scale | Standard Error 0.09 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3 | -1.3 Score on a scale | Standard Error 0.07 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-1.1, -0.8]ANCOVA
Secondary
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4
The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.
Time frame: Baseline and week 4 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4 | -0.5 Score on a scale | Standard Error 0.1 |
| Bisacodyl | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4 | -1.2 Score on a scale | Standard Error 0.08 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-0.9, -0.5]ANCOVA
Secondary
Change From Baseline in the PAC-QoL Overall Score
The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL
Time frame: Baseline and 4 weeks
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the PAC-QoL Overall Score | -0.1 Score on a scale | Standard Error 0.08 |
| Bisacodyl | Change From Baseline in the PAC-QoL Overall Score | -0.8 Score on a scale | Standard Error 0.06 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-0.8, -0.5]ANCOVA
Secondary
Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort'
The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL
Time frame: Baseline and 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort' | -0.2 Score on a scale | Standard Error 0.09 |
| Bisacodyl | Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort' | -1.0 Score on a scale | Standard Error 0.07 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-1, -0.7]ANCOVA
Secondary
Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort'
The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL
Time frame: Baseline and 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort' | -0.1 Score on a scale | Standard Error 0.07 |
| Bisacodyl | Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort' | -0.3 Score on a scale | Standard Error 0.06 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.00795% CI: [-0.3, -0.1]ANCOVA
Secondary
Change From Baseline in the PAC-QoL Subscale 'Satisfaction'
The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL
Time frame: Baseline and 4 weeks
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the PAC-QoL Subscale 'Satisfaction' | -0.2 Score on a scale | Standard Error 0.12 |
| Bisacodyl | Change From Baseline in the PAC-QoL Subscale 'Satisfaction' | -1.4 Score on a scale | Standard Error 0.1 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-1.5, -1]ANCOVA
Secondary
Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns'
The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL
Time frame: Baseline and 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns' | -0.1 Score on a scale | Standard Error 0.07 |
| Bisacodyl | Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns' | -0.6 Score on a scale | Standard Error 0.06 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [-0.6, -0.3]ANCOVA
Secondary
Change From Baseline in the SF-36 Dimension 'Bodily Pain'
The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Time frame: Baseline and 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the SF-36 Dimension 'Bodily Pain' | -2.3 Score on a scale | Standard Error 2.21 |
| Bisacodyl | Change From Baseline in the SF-36 Dimension 'Bodily Pain' | -0.2 Score on a scale | Standard Error 1.78 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.356795% CI: [-2.4, 6.7]ANCOVA
Secondary
Change From Baseline in the SF-36 Dimension 'General Health'
The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Time frame: Baseline and 4 weeks
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the SF-36 Dimension 'General Health' | -1.3 Score on a scale | Standard Error 1.28 |
| Bisacodyl | Change From Baseline in the SF-36 Dimension 'General Health' | 0.7 Score on a scale | Standard Error 1.03 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.140795% CI: [-0.7, 4.6]ANCOVA
Secondary
Change From Baseline in the SF-36 Dimension 'Mental Health'
The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Time frame: Baseline and 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the SF-36 Dimension 'Mental Health' | -2.9 Score on a scale | Standard Error 1.52 |
| Bisacodyl | Change From Baseline in the SF-36 Dimension 'Mental Health' | 0.6 Score on a scale | Standard Error 1.22 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.027395% CI: [0.4, 6.6]ANCOVA
Secondary
Change From Baseline in the SF-36 Dimension 'Physical Functioning'
The dimension is a sum of 10 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Time frame: Baseline and 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the SF-36 Dimension 'Physical Functioning' | -0.6 Score on a scale | Standard Error 1.92 |
| Bisacodyl | Change From Baseline in the SF-36 Dimension 'Physical Functioning' | -0.0 Score on a scale | Standard Error 1.55 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.79895% CI: [-3.4, 4.5]ANCOVA
Secondary
Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems'
The dimension is a sum of 3 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Time frame: Baseline and 4 weeks
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems' | -0.5 Score on a scale | Standard Error 1.85 |
| Bisacodyl | Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems' | 0.1 Score on a scale | Standard Error 1.49 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.754395% CI: [-3.2, 4.4]ANCOVA
Secondary
Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems'
The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Time frame: Baseline and 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems' | -0.2 Score on a scale | Standard Error 1.96 |
| Bisacodyl | Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems' | 0.9 Score on a scale | Standard Error 1.58 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.612995% CI: [-3, 5.1]ANCOVA
Secondary
Change From Baseline in the SF-36 Dimension 'Social Functioning'
The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Time frame: Baseline and 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the SF-36 Dimension 'Social Functioning' | -2.6 Score on a scale | Standard Error 2.04 |
| Bisacodyl | Change From Baseline in the SF-36 Dimension 'Social Functioning' | -1.5 Score on a scale | Standard Error 1.64 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.584995% CI: [-3, 5.3]ANCOVA
Secondary
Change From Baseline in the SF-36 Dimension 'Vitality'
The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.
Time frame: Baseline and 4 weeks
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the SF-36 Dimension 'Vitality' | -1.6 Score on a scale | Standard Error 1.66 |
| Bisacodyl | Change From Baseline in the SF-36 Dimension 'Vitality' | 2.7 Score on a scale | Standard Error 1.34 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.01395% CI: [0.9, 7.7]ANCOVA
Secondary
Change From Baseline in the SF-36 Mental Component Scale (MCS)
The MCS is a summary scale of the dimensions vitality, social functioning, role-emotional, and mental health. The component scale is norm-based to a standard population. A higher score indicates a better health.
Time frame: Baseline and 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the SF-36 Mental Component Scale (MCS) | -1.0 Score on a scale | Standard Error 0.82 |
| Bisacodyl | Change From Baseline in the SF-36 Mental Component Scale (MCS) | 0.3 Score on a scale | Standard Error 0.66 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.12995% CI: [-0.4, 3]ANCOVA
Secondary
Change From Baseline in the SF-36 Physical Component Scale (PCS)
The PCS is a summary scale of the subscales physical functioning, role-physical, bodily pain, and general health. The component scale is norm-based to a standard population. A higher score indicates a better health.
Time frame: Baseline and 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the SF-36 Physical Component Scale (PCS) | -0.4 Score on a scale | Standard Error 0.66 |
| Bisacodyl | Change From Baseline in the SF-36 Physical Component Scale (PCS) | 0.3 Score on a scale | Standard Error 0.53 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: 0.37895% CI: [-0.8, 2]ANCOVA
Secondary
Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period
A Spontaneous Bowel Movement (SBM) is a non-rescue medication-induced stool. The number of SBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.
Time frame: 4 Weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period | 5.1 SBMs per week | Standard Error 0.41 |
| Bisacodyl | Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period | 10.0 SBMs per week | Standard Error 0.33 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [4.1, 5.8]ANCOVA
Secondary
Number of CSBMs at Week 1
The number of CSBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time frame: Week 1 in treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of CSBMs at Week 1 | 2.0 CSBMs per week | Standard Error 0.4 |
| Bisacodyl | Number of CSBMs at Week 1 | 6.3 CSBMs per week | Standard Error 0.32 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [3.5, 5.2]ANCOVA
Secondary
Number of CSBMs at Week 2
The number of CSBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time frame: Week 2 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of CSBMs at Week 2 | 1.4 CSBMs per week | Standard Error 0.41 |
| Bisacodyl | Number of CSBMs at Week 2 | 4.9 CSBMs per week | Standard Error 0.33 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [2.7, 4.3]ANCOVA
Secondary
Number of CSBMs at Week 3
The number of CSBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time frame: Week 3 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of CSBMs at Week 3 | 1.8 CSBMs per week | Standard Error 0.38 |
| Bisacodyl | Number of CSBMs at Week 3 | 4.6 CSBMs per week | Standard Error 0.32 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [2, 3.6]ANCOVA
Secondary
Number of CSBMs at Week 4
The number of CSBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time frame: Week 4 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of CSBMs at Week 4 | 1.7 CSBMs per week | Standard Error 0.42 |
| Bisacodyl | Number of CSBMs at Week 4 | 4.3 CSBMs per week | Standard Error 0.35 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [1.8, 3.4]ANCOVA
Secondary
Number of Participants Using Rescue Medication at Week 1 in the Treatment Period
Time frame: Week 1 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Using Rescue Medication at Week 1 in the Treatment Period | 2 Participants |
| Bisacodyl | Number of Participants Using Rescue Medication at Week 1 in the Treatment Period | 1 Participants |
p-value: 0.252495% CI: [0.02, 2.67]Fisher Exact
Secondary
Number of Participants Using Rescue Medication at Week 2 in the Treatment Period
Time frame: Week 2 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Using Rescue Medication at Week 2 in the Treatment Period | 10 Participants |
| Bisacodyl | Number of Participants Using Rescue Medication at Week 2 in the Treatment Period | 4 Participants |
p-value: 0.003595% CI: [0.06, 0.63]Fisher Exact
Secondary
Number of Participants Using Rescue Medication at Week 3 in the Treatment Period
Time frame: Week 3 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Using Rescue Medication at Week 3 in the Treatment Period | 9 Participants |
| Bisacodyl | Number of Participants Using Rescue Medication at Week 3 in the Treatment Period | 1 Participants |
p-value: 0.000495% CI: [0.01, 0.46]Fisher Exact
Secondary
Number of Participants Using Rescue Medication at Week 4 in the Treatment Period
Time frame: Week 4 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Using Rescue Medication at Week 4 in the Treatment Period | 12 Participants |
| Bisacodyl | Number of Participants Using Rescue Medication at Week 4 in the Treatment Period | 6 Participants |
p-value: 0.008695% CI: [0.1, 0.69]Fisher Exact
Secondary
Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period
Time frame: 4 weeks
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period | 21 Participants |
| Bisacodyl | Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period | 8 Participants |
p-value: <0.000195% CI: [0.09, 0.41]Fisher Exact
Secondary
Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period
Time frame: 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period | 2 Participants |
| Bisacodyl | Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period | 70 Participants |
p-value: <0.000195% CI: [4.28, 68.66]Fisher Exact
Secondary
Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period
Time frame: 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period | 32 Participants |
| Bisacodyl | Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period | 161 Participants |
p-value: <0.000195% CI: [1.81, 3.35]Fisher Exact
Secondary
Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline
Time frame: Baseline and week 1 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline | 57 Participants |
| Bisacodyl | Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline | 204 Participants |
p-value: <0.000195% CI: [1.44, 2.13]Fisher Exact
Secondary
Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline
Time frame: Baseline and week 2 in treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline | 43 Participants |
| Bisacodyl | Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline | 178 Participants |
p-value: <0.000195% CI: [1.62, 2.66]Fisher Exact
Secondary
Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline
Time frame: Baseline and week 3 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline | 51 Participants |
| Bisacodyl | Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline | 163 Participants |
p-value: <0.000195% CI: [1.37, 2.11]Fisher Exact
Secondary
Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline
Time frame: Baseline and week 4 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline | 52 Participants |
| Bisacodyl | Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline | 148 Participants |
p-value: <0.000195% CI: [1.24, 1.88]Fisher Exact
Secondary
Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline
Time frame: Baseline and 4 weeks
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline | 47 Participants |
| Bisacodyl | Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline | 196 Participants |
p-value: <0.000195% CI: [1.62, 2.57]Fisher Exact
Secondary
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline
Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Time frame: Baseline and week 1 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline | Improved overall satisfaction | 44 Participants |
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline | Unchanged overall satisfaction | 46 Participants |
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline | Worsened overall satisfaction | 22 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline | Improved overall satisfaction | 153 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline | Unchanged overall satisfaction | 45 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline | Worsened overall satisfaction | 26 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline
Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Time frame: Baseline and week 2 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline | Improved overall satisfaction | 41 Participants |
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline | Unchanged overall satisfaction | 48 Participants |
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline | Worsened overall satisfaction | 22 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline | Improved overall satisfaction | 163 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline | Unchanged overall satisfaction | 37 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline | Worsened overall satisfaction | 12 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline
Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Time frame: Baseline and week 3 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline | Improved overall satisfaction | 44 Participants |
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline | Unchanged overall satisfaction | 43 Participants |
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline | Worsened overall satisfaction | 17 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline | Improved overall satisfaction | 153 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline | Unchanged overall satisfaction | 31 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline | Worsened overall satisfaction | 11 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline
Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline
Time frame: Baseline and week 4 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline | Improved overall satisfaction | 37 Participants |
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline | Unchanged overall satisfaction | 47 Participants |
| Placebo | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline | Worsened overall satisfaction | 14 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline | Improved overall satisfaction | 135 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline | Unchanged overall satisfaction | 32 Participants |
| Bisacodyl | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline | Worsened overall satisfaction | 8 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 1 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 33 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 47 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 32 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 136 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 59 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 29 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 2 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 31 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 46 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 34 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 142 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 43 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 27 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 3 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 27 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 45 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 32 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 129 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 49 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 17 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 4 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 25 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 46 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 27 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 107 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 49 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 19 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 1 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 37 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 46 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 29 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 93 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 62 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 69 Participants |
p-value: 0.6773Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 2 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 29 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 49 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 33 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 104 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 67 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 41 Participants |
p-value: 0.0002Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 3 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 34 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 33 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 37 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 101 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 63 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 31 Participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 4 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 31 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 36 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 31 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 97 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 46 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 32 Participants |
p-value: 0.0005Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 1 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 36 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 51 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 25 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 168 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 46 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 10 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 2 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 35 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 45 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 31 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 160 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 36 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 16 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 3 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 39 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 41 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 24 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 147 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 30 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 18 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline
Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline
Time frame: Baseline and week 4 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 21 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 30 Participants |
| Placebo | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 47 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline | Reduced bothersomeness | 125 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline | Unchanged bothersomeness | 35 Participants |
| Bisacodyl | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline | Increased bothersomeness | 15 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator
Final global assessment scale range: 1 (good) to 4 (bad), ordinal
Time frame: 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator | Good | 26 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator | Not satisfactory | 30 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator | Satisfactory | 37 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator | Bad | 24 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator | Bad | 6 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator | Good | 156 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator | Satisfactory | 59 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator | Not satisfactory | 18 Participants |
p-value: <0.0001Wilcoxon rank sum test
Secondary
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient
Final global assessment scale range: 1 (good) to 4 (bad), ordinal
Time frame: 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient | Good | 23 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient | Satisfactory | 35 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient | Not satisfactory | 40 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient | Bad | 19 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient | Bad | 22 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient | Good | 132 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient | Not satisfactory | 27 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient | Satisfactory | 58 Participants |
p-value: <0.0001Wilcoxon rank sum test
Secondary
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator
Final global assessment scale range: 1 (good) to 4 (bad), ordinal
Time frame: 4 weeks
Population: Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator | Good | 75 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator | Satisfactory | 31 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator | Not satisfactory | 10 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator | Bad | 1 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator | Bad | 27 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator | Good | 85 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator | Not satisfactory | 43 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator | Satisfactory | 84 Participants |
p-value: <0.0001Wilcoxon rank sum test
Secondary
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient
Final global assessment scale range: 1 (good) to 4 (bad), ordinal
Time frame: 4 weeks
Population: Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient | Bad | 10 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient | Satisfactory | 50 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient | Not satisfactory | 19 Participants |
| Placebo | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient | Good | 38 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient | Not satisfactory | 22 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient | Good | 125 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient | Bad | 27 Participants |
| Bisacodyl | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient | Satisfactory | 65 Participants |
p-value: 0.0058Wilcoxon rank sum test
Secondary
Number of Premature Withdrawals at Week 1 in the Treatment Period
Time frame: Week 1 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Premature Withdrawals at Week 1 in the Treatment Period | 3 Participants |
| Bisacodyl | Number of Premature Withdrawals at Week 1 in the Treatment Period | 25 Participants |
p-value: 0.010595% CI: [1.26, 13.24]Fisher Exact
Secondary
Number of Premature Withdrawals at Week 2 in the Treatment Period
Time frame: Week 2 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Premature Withdrawals at Week 2 in the Treatment Period | 3 Participants |
| Bisacodyl | Number of Premature Withdrawals at Week 2 in the Treatment Period | 11 Participants |
p-value: 0.400295% CI: [0.52, 6.47]Fisher Exact
Secondary
Number of Premature Withdrawals at Week 3 in the Treatment Period
Time frame: Week 3 in the treatment period
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Premature Withdrawals at Week 3 in the Treatment Period | 4 Participants |
| Bisacodyl | Number of Premature Withdrawals at Week 3 in the Treatment Period | 9 Participants |
p-value: 195% CI: [0.37, 3.77]Fisher Exact
Secondary
Number of Premature Withdrawals at Week 4 in the Treatment Period
Time frame: Week 4 in the treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Premature Withdrawals at Week 4 in the Treatment Period | 0 Participants |
| Bisacodyl | Number of Premature Withdrawals at Week 4 in the Treatment Period | 6 Participants |
p-value: 0.0951Fisher Exact
Secondary
Number of Premature Withdrawals Over the 4 Weeks Treatment Period
Time frame: 4 weeks
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Premature Withdrawals Over the 4 Weeks Treatment Period | 10 Participants |
| Bisacodyl | Number of Premature Withdrawals Over the 4 Weeks Treatment Period | 51 Participants |
p-value: 0.002595% CI: [1.32, 4.74]Fisher Exact
Secondary
Number of SBMs at Week 1
The number of SBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time frame: Week 1 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of SBMs at Week 1 | 5.3 SBMs per week | Standard Error 0.46 |
| Bisacodyl | Number of SBMs at Week 1 | 12.1 SBMs per week | Standard Error 0.37 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [5.8, 7.7]ANCOVA
Secondary
Number of SBMs at Week 2
The number of SBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time frame: Week 2 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of SBMs at Week 2 | 4.9 SBMs per week | Standard Error 0.44 |
| Bisacodyl | Number of SBMs at Week 2 | 9.6 SBMs per week | Standard Error 0.36 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [3.8, 5.6]ANCOVA
Secondary
Number of SBMs at Week 3
The number of SBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time frame: Week 3 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of SBMs at Week 3 | 4.8 SBMs per week | Standard Error 0.44 |
| Bisacodyl | Number of SBMs at Week 3 | 8.6 SBMs per week | Standard Error 0.36 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [2.9, 4.7]ANCOVA
Secondary
Number of SBMs at Week 4
The number of SBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.
Time frame: Week 4 in treatment period
Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of SBMs at Week 4 | 4.0 SBMs per week | Standard Error 0.42 |
| Bisacodyl | Number of SBMs at Week 4 | 7.8 SBMs per week | Standard Error 0.36 |
Comparison: Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariatep-value: <0.000195% CI: [2.9, 4.6]ANCOVA
Secondary
Time to the First SBM Following the First Dose of Study Medication (SM)
The time to the first SBM following the first dose of SM was captured by the eDiary. The time was censored by the time of intake of rescue medication (RM), the time of premature discontinuation or the end of treatment whatever was minimal.
Time frame: Time of first dose of SM up to 4 weeks
Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to the First SBM Following the First Dose of Study Medication (SM) | 19 Hours |
| Bisacodyl | Time to the First SBM Following the First Dose of Study Medication (SM) | 12 Hours |
Comparison: The log-rank test was used to calculate the p-value and to test for differences between the treatment groups.p-value: <0.0001Log Rank