Constipation
Conditions
Brief summary
The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping. In addition, the proportion of subjects with a BM (without straining and without hard and/or lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E was evaluated for the time to first BM.
Interventions
DRUGPEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A willingness to participate in the study and comply with its procedures * Must be ambulatory * Male or female subjects aged 18 years or older who met two or more of the following modified Rome III-based criteria for constipation: (a) straining during at least 25% of defecations; (b) lumpy or hard stools in at least 25% of defecations; (c) sensation of incomplete evacuation for at least 25% of defecation; (d) sensation of anorectal obstruction/blockage for at least 25% of defecations; (e) manual maneuvers to facilitate at least 25% of defecations (eg, digital evacuation, support of the pelvic floor), and (f) fewer than 3 defecations per week * Criteria fulfilled for the last 3 months with symptom onset at least 6 mo prior to diagnosis * Had a self reported or documented history of chronic constipation * Agreed not to use laxatives other than the study treatment from baseline/informed consent to end-of-study * Agreed to maintain a similar diet from the week before Visit 3 to the end-of-study were to be enrolled * Additionally required not to use any treatment known to cause constipation during the study (for subjects enrolled after Amendment 1) * If a female subject, either surgically sterile, 2 years postmenopausal, or using an acceptable method of contraception. Abstinence was not an acceptable method of contraception. Females of childbearing potential had to have a urine pregnancy test (human chorionic gonadotropin \[HCG\]) that was negative at Visit 3 * Be able to read and write in the diaries in English
Exclusion criteria
* Had loose stools without the use of laxatives * Recurrent abdominal pain * Known or suspected bowel perforation, obstruction, or fecal impaction; or had gastric retention, inflammatory bowel disease, bowel resection, or colostomy * Celiac disease or known gluten sensitivity * Known renal or hepatic insufficiency * Recent history of alcohol abuse or drug abuse * History of psychiatric disorders * History of significant ongoing medical problems or scheduled for surgical procedures * Subjects who, in the opinion of the Investigator, should not have been included in the study for any reason, including inability to follow study procedures * Participated in an investigational clinical, surgical, drug or device study within the past 30 days * Pregnant or lactating * Allergic to PEG or PEG+E * Employed by or have immediate family members employed by a company that manufactures laxative products * Participant or family member of the Investigator or site staff directly involved with this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration | From time of study drug treatment up to 24 hours | A successful BM was defined as a BM with no straining or hard/lumpy stools. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration | From time of study drug treatment up to 12 hours | A successful BM was defined as a BM with no straining or hard/lumpy stools. |
| Mean Visual Analog Scale (VAS) Rating for BM Control | From time of study drug treatment up to 24 hours | The VAS is a psychometric response scale which measures responses along a continuum of values. The BM control VAS uses a 100 mm horizontal line with the two ends representing the opposite, extreme limits of the participant's experience of BM control. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. BM Control ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=Calm, not urgent and 100 mm= Not able to hold BM, very urgent. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group |
| Mean VAS Rating for Gas | From time of study drug treatment up to 24 hours | The VAS is a psychometric response scale which measures responses along a continuum of values. The Gas VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related gas. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Gas ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group. |
| Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration | From time of study drug administration up to 3 Days | Time to first successful bowel movement was defined as the duration (in days) from the time of first study dose of study treatment until first successful BM (defined as BM without straining and without hard and/or lumpy stool). |
| Mean VAS Rating for Abdominal Discomfort/Cramping | From time of study drug treatment up to 24 hours | The VAS is a psychometric response scale which measures responses along a continuum of values. The Abdominal Discomfort/Cramping VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related abdominal discomfort/cramping. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Abdominal discomfort/cramping ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Painful. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group. |
| Mean Participant Global Assessment of Treatment | From time of study drug administration up to 2 Days | At the End of Study Visit, the study staff asked the participant to rate their global assessment of the study treatment according to the following categories: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. |
| Mean VAS Rating for Bloating | From time of study drug treatment up to 24 hours | The VAS is a psychometric response scale which measures responses along a continuum of values. The Bloating VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related bloating. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Bloating ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group. |
Countries
Ireland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PEG + E 13.125 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment | 52 |
| PEG + E 26.25 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment. | 51 |
| PEG + E 39.375 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment. | 51 |
| Total | 154 |
Baseline characteristics
| Characteristic | PEG + E 13.125 g | PEG + E 26.25 g | PEG + E 39.375 g | Total |
|---|---|---|---|---|
| Age, Continuous | 45.9 years STANDARD_DEVIATION 16.31 | 50.4 years STANDARD_DEVIATION 14.27 | 43.3 years STANDARD_DEVIATION 13.8 | 46.5 years STANDARD_DEVIATION 14.85 |
| Sex: Female, Male Female | 48 Participants | 44 Participants | 41 Participants | 133 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 52 | 0 / 51 | 0 / 51 |
Outcome results
Primary
Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration
A successful BM was defined as a BM with no straining or hard/lumpy stools.
Time frame: From time of study drug treatment up to 24 hours
Population: Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG + E 13.125 g | Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration | 19.2 percentage of participants |
| PEG + E 26.25 g | Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration | 31.4 percentage of participants |
| PEG + E 39.375 g | Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration | 19.2 percentage of participants |
Comparison: The treatment success rate was defined as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).p-value: 0.17995% CI: [0.096, 0.325]Fisher Exact
Comparison: The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).p-value: 195% CI: [0.191, 0.459]Fisher Exact
Comparison: The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).p-value: 0.255895% CI: [0.098, 0.331]Fisher Exact
Comparison: Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence interval. There were no multiplicity adjustments.95% CI: [0.774, 4.763]Regression, Logistic
Comparison: Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments.95% CI: [0.386, 2.72]Regression, Logistic
Secondary
Mean Participant Global Assessment of Treatment
At the End of Study Visit, the study staff asked the participant to rate their global assessment of the study treatment according to the following categories: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.
Time frame: From time of study drug administration up to 2 Days
Population: Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEG + E 13.125 g | Mean Participant Global Assessment of Treatment | 1.0 units on a scale | Standard Deviation 1.15 |
| PEG + E 26.25 g | Mean Participant Global Assessment of Treatment | 1.3 units on a scale | Standard Deviation 1.26 |
| PEG + E 39.375 g | Mean Participant Global Assessment of Treatment | 1.2 units on a scale | Standard Deviation 1.2 |
p-value: 0.186595% CI: [-0.774, 0.152]ANCOVA
p-value: 0.55395% CI: [-0.602, 0.323]ANCOVA
p-value: 0.46795% CI: [-0.293, 0.637]ANCOVA
Secondary
Mean VAS Rating for Abdominal Discomfort/Cramping
The VAS is a psychometric response scale which measures responses along a continuum of values. The Abdominal Discomfort/Cramping VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related abdominal discomfort/cramping. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Abdominal discomfort/cramping ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Painful. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.
Time frame: From time of study drug treatment up to 24 hours
Population: Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEG + E 13.125 g | Mean VAS Rating for Abdominal Discomfort/Cramping | 17.4 mm | Standard Deviation 24.91 |
| PEG + E 26.25 g | Mean VAS Rating for Abdominal Discomfort/Cramping | 14.0 mm | Standard Deviation 22.56 |
| PEG + E 39.375 g | Mean VAS Rating for Abdominal Discomfort/Cramping | 14.5 mm | Standard Deviation 16.89 |
p-value: 0.459195% CI: [-6.153, 13.534]ANCOVA
p-value: 0.554695% CI: [-6.765, 12.539]ANCOVA
p-value: 0.868595% CI: [-10.397, 8.79]ANCOVA
Secondary
Mean VAS Rating for Bloating
The VAS is a psychometric response scale which measures responses along a continuum of values. The Bloating VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related bloating. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Bloating ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.
Time frame: From time of study drug treatment up to 24 hours
Population: Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEG + E 13.125 g | Mean VAS Rating for Bloating | 33.9 mm | Standard Deviation 32.39 |
| PEG + E 26.25 g | Mean VAS Rating for Bloating | 21.7 mm | Standard Deviation 25.1 |
| PEG + E 39.375 g | Mean VAS Rating for Bloating | 32.7 mm | Standard Deviation 29.55 |
p-value: 0.048695% CI: [0.078, 25.695]ANCOVA
p-value: 0.846595% CI: [-11.471, 13.962]ANCOVA
p-value: 0.074495% CI: [-24.449, 1.167]ANCOVA
Secondary
Mean VAS Rating for Gas
The VAS is a psychometric response scale which measures responses along a continuum of values. The Gas VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related gas. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Gas ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group.
Time frame: From time of study drug treatment up to 24 hours
Population: Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEG + E 13.125 g | Mean VAS Rating for Gas | 23.9 mm | Standard Deviation 21.87 |
| PEG + E 26.25 g | Mean VAS Rating for Gas | 25.4 mm | Standard Deviation 27.14 |
| PEG + E 39.375 g | Mean VAS Rating for Gas | 26.0 mm | Standard Deviation 22.93 |
p-value: 0.810995% CI: [-12.059, 9.454]ANCOVA
p-value: 0.699595% CI: [-12.693, 8.544]ANCOVA
p-value: 0.88595% CI: [-11.329, 9.784]ANCOVA
Secondary
Mean Visual Analog Scale (VAS) Rating for BM Control
The VAS is a psychometric response scale which measures responses along a continuum of values. The BM control VAS uses a 100 mm horizontal line with the two ends representing the opposite, extreme limits of the participant's experience of BM control. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. BM Control ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=Calm, not urgent and 100 mm= Not able to hold BM, very urgent. Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group
Time frame: From time of study drug treatment up to 24 hours
Population: Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEG + E 13.125 g | Mean Visual Analog Scale (VAS) Rating for BM Control | 31.1 mm | Standard Deviation 27.27 |
| PEG + E 26.25 g | Mean Visual Analog Scale (VAS) Rating for BM Control | 23.5 mm | Standard Deviation 23.76 |
| PEG + E 39.375 g | Mean Visual Analog Scale (VAS) Rating for BM Control | 29.4 mm | Standard Deviation 23.59 |
p-value: 0.187695% CI: [-3.834, 19.338]ANCOVA
p-value: 0.76895% CI: [-9.729, 13.141]ANCOVA
p-value: 0.294195% CI: [-17.412, 5.32]ANCOVA
Secondary
Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration
Time to first successful bowel movement was defined as the duration (in days) from the time of first study dose of study treatment until first successful BM (defined as BM without straining and without hard and/or lumpy stool).
Time frame: From time of study drug administration up to 3 Days
Population: Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had a successful bowel movement (no straining or hard/lumpy stools). Participants who reported no successful BMs were censored.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG + E 13.125 g | Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration | Successful BM in >1.0 days through 1.5 days | 1 participants |
| PEG + E 13.125 g | Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration | Successful BM in 0 days through 0.5 days | 4 participants |
| PEG + E 13.125 g | Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration | Successful BM in >0.5 days through 1.0 days | 6 participants |
| PEG + E 26.25 g | Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration | Successful BM in >0.5 days through 1.0 days | 8 participants |
| PEG + E 26.25 g | Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration | Successful BM in >1.0 days through 1.5 days | 0 participants |
| PEG + E 26.25 g | Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration | Successful BM in 0 days through 0.5 days | 8 participants |
| PEG + E 39.375 g | Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration | Successful BM in 0 days through 0.5 days | 6 participants |
| PEG + E 39.375 g | Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration | Successful BM in >1.0 days through 1.5 days | 2 participants |
| PEG + E 39.375 g | Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration | Successful BM in >0.5 days through 1.0 days | 4 participants |
Secondary
Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration
A successful BM was defined as a BM with no straining or hard/lumpy stools.
Time frame: From time of study drug treatment up to 12 hours
Population: Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG + E 13.125 g | Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration | 7.7 percentage of participants |
| PEG + E 26.25 g | Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration | 15.7 percentage of participants |
| PEG + E 39.375 g | Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration | 11.8 percentage of participants |
Comparison: The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).p-value: 0.23595% CI: [0.021, 0.185]Fisher Exact
Comparison: The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).p-value: 0.525695% CI: [0.07, 0.286]Fisher Exact
Comparison: The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).p-value: 0.774695% CI: [0.044, 0.239]Fisher Exact
Comparison: Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments.95% CI: [0.628, 7.94]Regression, Logistic
Comparison: Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments.95% CI: [0.424, 6.043]Regression, Logistic