Abdominal Pain
Conditions
Brief summary
The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB) 20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment of intensity of abdominal pain associated with cramping (APC) in the treatment of two episodes.
Interventions
DRUGPlacebo
1-5 tablets per episode
DRUGHBB 20 mg
Active drug, one to five tablets per episode
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
History of recurrent abdominal pain with cramping (APC) for at least three months. Recorded at least two episodes of APC of at least moderate intensity (i.e., 5 or above on a 0-10 point scale) lasting one hour in the eDiary during the run-in period.
Exclusion criteria
Experiencing daily episode of APC during Run-in period Active gastrointestinal disease during the past 12 months including malignancy, inflammatory bowel disease, celiac disease or complete or partial bowel obstruction and who have undergone major gastrointestinal surgery with the past 12 months (patients with history of appendectomy, cholecystectomy, bilateral tubal ligation and c-section within past 12 months are allowed in the study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Tablets of Study Medication Taken | From intake of first tablet of study medication up to 4 hours thereafter in each episode. | Number of tablets of study medication taken in each of the two episode. |
| Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 1 | At 4 hours after intake of first tablet of study medication in episode 1 | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of no pain (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized. |
| Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2 | At 4 hours after intake of first tablet of study medication in episode 2 | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of no pain (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized. |
| Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of Much Better in Episode 1 | At 4 hours after intake of first tablet of study medication in episode 1 | At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now? based on the Patient global impression of change (PGI-C), using the available responses: Much better, Somewhat better, A little better, No change, A little worse, and Somewhat worse. |
| Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of Much Better in Episode 2 | At 4 hours after intake of first tablet of study medication in episode 2 | At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now? based on the Patient global impression of change (PGI-C), using the available responses: Much better, Somewhat better, A little better, No change, A little worse, and Somewhat worse. |
| Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of Very Satisfied in Episode 1 | At 4 hours after intake of first tablet of study medication in episode 1 | At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of Overall, how satisfied were you with the medication in terms of effectiveness for this episode? based on the 4-point Verbal rating scale (VRS) using the available response: Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied. |
| Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of Very Satisfied in Episode 2 | At 4 hours after intake of first tablet of study medication in episode 2 | At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of Overall, how satisfied were you with the medication in terms of effectiveness for this episode? based on the 4-point Verbal rating scale (VRS) using the available response: Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied. |
| Time to Relief in Episode 1 | From intake of first tablet of study medication up to 4 hours thereafter in episode 1 | Time from intake of first tablet of study medication to first response of no pain (numeric pain rating scale (NPRS) = 0) in episode 1. |
| Time to Relief in Episode 2 | From intake of first tablet of study medication up to 4 hours thereafter in episode 2 | Time from intake of first tablet of study medication to first response of no pain (numeric pain rating scale (NPRS) = 0) in episode 2. |
| Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1 | At baseline (prior to intake of first tablet of study medication in episode 1) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). |
| Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2 | At baseline (prior to intake of first tablet of study medication in episode 2) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours. | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). |
| Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1 | At baseline (prior to intake of first tablet of study medication for episode 1) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter. | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). |
| Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2 | At baseline (prior to intake of first tablet of study medication for episode 2) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter. | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 | At 4 hours after intake of first tablet of study medication in episode 1 | Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, Overall, how satisfied were you with the medication in terms of side effects during this episode? (Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied). |
| Change From Baseline to End of Study Visit in Systolic Blood Pressure | At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit) | Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in systolic blood pressure. |
| Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 | At 4 hours after intake of first tablet of study medication in episode 2 | Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, Overall, how satisfied were you with the medication in terms of side effects during this episode? (Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied) |
| Change From Baseline to End of Study Visit in Diastolic Blood Pressure | At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit | Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in diastolic blood pressure. |
| Change From Baseline to End of Study Visit in Pulse Rate | At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit | Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in pulse rate. |
| Change From Baseline to End of Study Visit in Body Temperature | At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit | Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in body temperature. |
| Change From Baseline to End of Study Visit in Respiratory Rate | At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit | Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in respiratory rate. |
| Percentage of Patients With Drug-related Adverse Events | From the first dose of study medication until 3 days after the last dose for each episode. Up to 8 days. | — |
Countries
United States
Participant flow
Recruitment details
This double-blind, placebo-controlled, randomized, parallel-group pilot study aimed to assess the efficacy and safety of oral doses of 20 milligram hyoscine butylbromide when used on demand for the treatment of abdominal pain associated with cramping over a treatment period of 4 weeks.
Pre-assignment details
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. 22 enrolled subjects didn't receive any trial medication
Participants by arm
| Arm | Count |
|---|---|
| Placebo Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | 87 |
| Hyoscine Butylbromide (Buscopan®) 20 mg Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | 88 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Not treated in second episode | 1 | 0 |
Baseline characteristics
| Characteristic | Hyoscine Butylbromide (Buscopan®) 20 mg | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 39.7 Years STANDARD_DEVIATION 15 | 38.4 Years STANDARD_DEVIATION 13.3 | 37.0 Years STANDARD_DEVIATION 11.3 |
| Numeric pain rating scale (NPRS) for intensity of APC in episode 1 | 7.57 Score on a scale STANDARD_DEVIATION 1.42 | 7.62 Score on a scale STANDARD_DEVIATION 1.55 | 7.67 Score on a scale STANDARD_DEVIATION 1.67 |
| Numeric pain rating scale (NPRS) for intensity of APC in episode 2 | 7.73 Score on a scale STANDARD_DEVIATION 1.44 | 7.79 Score on a scale STANDARD_DEVIATION 1.47 | 7.86 Score on a scale STANDARD_DEVIATION 1.51 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 67 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 106 Participants | 52 Participants |
| Sex: Female, Male Female | 62 Participants | 130 Participants | 68 Participants |
| Sex: Female, Male Male | 26 Participants | 45 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 88 |
| other Total, other adverse events | 0 / 87 | 0 / 88 |
| serious Total, serious adverse events | 0 / 87 | 1 / 88 |
Outcome results
Primary
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: At baseline (prior to intake of first tablet of study medication for episode 1) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1 | -3.71 Score * hours | Standard Deviation 2.42 |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1 | -4.32 Score * hours | Standard Deviation 2.27 |
Comparison: The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.p-value: 0.035195% CI: [-1.3, 0]ANCOVA
Primary
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: At baseline (prior to intake of first tablet of study medication for episode 2) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2 | -4.17 Score * hours | Standard Deviation 2.51 |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2 | -4.40 Score * hours | Standard Deviation 2.32 |
Comparison: The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.p-value: 0.355795% CI: [-1, 0.4]ANCOVA
Primary
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: At baseline (prior to intake of first tablet of study medication in episode 1) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1 | -2.7 Score on a scale | Standard Deviation 3.1 |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1 | -3.1 Score on a scale | Standard Deviation 3.05 |
Comparison: A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.p-value: 0.015695% CI: [-1.3, -0.1]Mixed effect model
Primary
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: At baseline (prior to intake of first tablet of study medication in episode 2) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours.
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2 | -2.9 Score on a scale | Standard Deviation 3.15 |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2 | -3.2 Score on a scale | Standard Deviation 3.06 |
Comparison: A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.p-value: 0.051295% CI: [-1.2, 0]Mixed effect model
Primary
Number of Tablets of Study Medication Taken
Number of tablets of study medication taken in each of the two episode.
Time frame: From intake of first tablet of study medication up to 4 hours thereafter in each episode.
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Tablets of Study Medication Taken | Episode 1 | 3.5 Tablets | Standard Deviation 1.2 |
| Placebo | Number of Tablets of Study Medication Taken | Episode 2 | 3.1 Tablets | Standard Deviation 1.5 |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Number of Tablets of Study Medication Taken | Episode 1 | 3.3 Tablets | Standard Deviation 1.3 |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Number of Tablets of Study Medication Taken | Episode 2 | 3.0 Tablets | Standard Deviation 1.4 |
Primary
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of Very Satisfied in Episode 1
At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of Overall, how satisfied were you with the medication in terms of effectiveness for this episode? based on the 4-point Verbal rating scale (VRS) using the available response: Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied.
Time frame: At 4 hours after intake of first tablet of study medication in episode 1
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of Very Satisfied in Episode 1 | 15.79 Percentage of participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of Very Satisfied in Episode 1 | 30.43 Percentage of participants |
p-value: 0.0395% CI: [1.093, 5.604]Regression, Logistic
Primary
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of Very Satisfied in Episode 2
At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of Overall, how satisfied were you with the medication in terms of effectiveness for this episode? based on the 4-point Verbal rating scale (VRS) using the available response: Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied.
Time frame: At 4 hours after intake of first tablet of study medication in episode 2
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of Very Satisfied in Episode 2 | 32.31 Percentage of participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of Very Satisfied in Episode 2 | 43.33 Percentage of participants |
p-value: 0.16795% CI: [0.81, 3.378]Regression, Logistic
Primary
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of Much Better in Episode 1
At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now? based on the Patient global impression of change (PGI-C), using the available responses: Much better, Somewhat better, A little better, No change, A little worse, and Somewhat worse.
Time frame: At 4 hours after intake of first tablet of study medication in episode 1
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of Much Better in Episode 1 | 79.31 Percentage of participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of Much Better in Episode 1 | 73.86 Percentage of participants |
p-value: 0.39695% CI: [0.365, 1.49]Regression, Logistic
Primary
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of Much Better in Episode 2
At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now? based on the Patient global impression of change (PGI-C), using the available responses: Much better, Somewhat better, A little better, No change, A little worse, and Somewhat worse.
Time frame: At 4 hours after intake of first tablet of study medication in episode 2
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of Much Better in Episode 2 | 76.39 Percentage of participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of Much Better in Episode 2 | 80.77 Percentage of participants |
p-value: 0.44895% CI: [0.632, 2.827]Regression, Logistic
Primary
Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 1
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of no pain (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.
Time frame: At 4 hours after intake of first tablet of study medication in episode 1
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 1 | 65.52 Percentage of participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 1 | 67.05 Percentage of participants |
p-value: 0.83195% CI: [0.572, 2.004]Regression, Logistic
Primary
Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of no pain (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.
Time frame: At 4 hours after intake of first tablet of study medication in episode 2
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2 | 69.44 Percentage of participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2 | 71.79 Percentage of participants |
p-value: 0.55795% CI: [0.626, 2.387]Regression, Logistic
Primary
Time to Relief in Episode 1
Time from intake of first tablet of study medication to first response of no pain (numeric pain rating scale (NPRS) = 0) in episode 1.
Time frame: From intake of first tablet of study medication up to 4 hours thereafter in episode 1
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Relief in Episode 1 | 172.0 Minutes |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Time to Relief in Episode 1 | 130.0 Minutes |
p-value: 0.256Log Rank
Primary
Time to Relief in Episode 2
Time from intake of first tablet of study medication to first response of no pain (numeric pain rating scale (NPRS) = 0) in episode 2.
Time frame: From intake of first tablet of study medication up to 4 hours thereafter in episode 2
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Relief in Episode 2 | 150.0 Minutes |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Time to Relief in Episode 2 | 120.0 Minutes |
p-value: 0.5179Log Rank
Secondary
Change From Baseline to End of Study Visit in Body Temperature
Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in body temperature.
Time frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Study Visit in Body Temperature | -0.053 celsius | Standard Deviation 0.508 |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Change From Baseline to End of Study Visit in Body Temperature | -0.036 celsius | Standard Deviation 0.367 |
Secondary
Change From Baseline to End of Study Visit in Diastolic Blood Pressure
Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in diastolic blood pressure.
Time frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Study Visit in Diastolic Blood Pressure | 0.21 millimetre of mercury (mmHg) | Standard Deviation 7.19 |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Change From Baseline to End of Study Visit in Diastolic Blood Pressure | 0.82 millimetre of mercury (mmHg) | Standard Deviation 8.37 |
Secondary
Change From Baseline to End of Study Visit in Pulse Rate
Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in pulse rate.
Time frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Study Visit in Pulse Rate | -0.9 beats per minute (bpm) | Standard Deviation 11.1 |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Change From Baseline to End of Study Visit in Pulse Rate | 0.8 beats per minute (bpm) | Standard Deviation 9.1 |
Secondary
Change From Baseline to End of Study Visit in Respiratory Rate
Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in respiratory rate.
Time frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Study Visit in Respiratory Rate | 0.0 breaths per minute | Standard Deviation 2.4 |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Change From Baseline to End of Study Visit in Respiratory Rate | 0.2 breaths per minute | Standard Deviation 2.2 |
Secondary
Change From Baseline to End of Study Visit in Systolic Blood Pressure
Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in systolic blood pressure.
Time frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit)
Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Study Visit in Systolic Blood Pressure | 2.52 millimetre of mercury (mmHg) | Standard Deviation 11.79 |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Change From Baseline to End of Study Visit in Systolic Blood Pressure | -0.76 millimetre of mercury (mmHg) | Standard Deviation 10.84 |
Secondary
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1
Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, Overall, how satisfied were you with the medication in terms of side effects during this episode? (Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied).
Time frame: At 4 hours after intake of first tablet of study medication in episode 1
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 | Very satisfied | 24 Participants |
| Placebo | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 | Satisfied | 45 Participants |
| Placebo | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 | Dissatisfied | 7 Participants |
| Placebo | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 | Very dissatisfied | 0 Participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 | Very dissatisfied | 0 Participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 | Very satisfied | 36 Participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 | Dissatisfied | 4 Participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 | Satisfied | 29 Participants |
Secondary
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2
Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, Overall, how satisfied were you with the medication in terms of side effects during this episode? (Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied)
Time frame: At 4 hours after intake of first tablet of study medication in episode 2
Population: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 | Very satisfied | 27 Participants |
| Placebo | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 | Satisfied | 34 Participants |
| Placebo | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 | Dissatisfied | 3 Participants |
| Placebo | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 | Very dissatisfied | 1 Participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 | Very dissatisfied | 0 Participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 | Very satisfied | 34 Participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 | Dissatisfied | 1 Participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 | Satisfied | 25 Participants |
Secondary
Percentage of Patients With Drug-related Adverse Events
Time frame: From the first dose of study medication until 3 days after the last dose for each episode. Up to 8 days.
Population: Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Patients With Drug-related Adverse Events | 4.6 Percentage of participants |
| Hyoscine Butylbromide (Buscopan®) 20 mg | Percentage of Patients With Drug-related Adverse Events | 3.4 Percentage of participants |