Opioid-Induced Bowel Dysfunction
Conditions
Brief summary
The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.
Interventions
DRUGLubiprostone 24
24 mcg capsules for oral administration
Sponsors
Sucampo Pharma Americas, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428 * Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study * Willing to continue to abstain from use of disallowed medications as defined per protocol
Exclusion criteria
* Has newly diagnosed impaired renal function identified at the Screening Visit \[i.e., serum creatinine concentration \> 1.8 milligrams per deciliter (mg/dL)\] * Has experienced an unexplained and/or clinically significant weight loss defined as \> 5% within 90 days prior to Screening Visit. * Has plans to participate in another trial with an investigational drug or device during the course of the extension study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication. |
| Mean Weekly Bowel Movements (BMs) Per Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | A Bowel Movement (BM) is defined as any BM (whether spontaneous or not) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool Consistency of Spontaneous Bowel Movements by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2. |
| Constipation Severity by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0. |
| Abdominal Bloating by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0. |
| Abdominal Discomfort by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0. |
| Number of Participants Classified as Monthly Responders | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed). A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder. |
| Treatment Effectiveness by Month | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The highest and best score is 4. |
| Mean Weekly Complete SBMs by Month | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate each SBM as complete if their bowels feel completely empty after the SBM |
| Mean Weekly Complete BMs by Month | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate each BM as complete if their bowels feel completely empty after the BM |
| Bowel Habit Regularity by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular. The highest score is 7, but the best score is 1. |
| Straining Associated With Spontaneous Bowel Movements by Month | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better. |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were enrolled from 4 December 2007 to 29 September 2009 at 137 recruitment sites in the United States (n=134) and Canada (n=3)
Participants by arm
| Arm | Count |
|---|---|
| Lubiprostone Lubiprostone: 24 mcg capsules twice daily (BID) for 36 weeks | 439 |
| Total | 439 |
Baseline characteristics
| Characteristic | Lubiprostone |
|---|---|
| Age, Continuous | 49.8 Years STANDARD_DEVIATION 9.99 |
| Region of Enrollment Canada | 3 participants |
| Region of Enrollment United States | 436 participants |
| Sex: Female, Male Female | 263 Participants |
| Sex: Female, Male Male | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 439 |
| other Total, other adverse events | 100 / 439 |
| serious Total, serious adverse events | 34 / 439 |
Outcome results
Primary
Mean Weekly Bowel Movements (BMs) Per Month
A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat population with evaluable BM data during the given month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Weekly Bowel Movements (BMs) Per Month | Month 2 | 5.0 Weekly BMs | Standard Deviation 2.63 |
| All Participants | Mean Weekly Bowel Movements (BMs) Per Month | Baseline | 2.4 Weekly BMs | Standard Deviation 1.38 |
| All Participants | Mean Weekly Bowel Movements (BMs) Per Month | Month 1 | 5.0 Weekly BMs | Standard Deviation 2.73 |
| All Participants | Mean Weekly Bowel Movements (BMs) Per Month | Month 3 | 5.2 Weekly BMs | Standard Deviation 2.7 |
| All Participants | Mean Weekly Bowel Movements (BMs) Per Month | Month 4 | 5.1 Weekly BMs | Standard Deviation 2.67 |
| All Participants | Mean Weekly Bowel Movements (BMs) Per Month | Month 5 | 5.1 Weekly BMs | Standard Deviation 2.79 |
| All Participants | Mean Weekly Bowel Movements (BMs) Per Month | Month 6 | 5.1 Weekly BMs | Standard Deviation 2.85 |
| All Participants | Mean Weekly Bowel Movements (BMs) Per Month | Month 7 | 5.2 Weekly BMs | Standard Deviation 2.9 |
| All Participants | Mean Weekly Bowel Movements (BMs) Per Month | Month 8 | 5.4 Weekly BMs | Standard Deviation 2.88 |
| All Participants | Mean Weekly Bowel Movements (BMs) Per Month | Month 9 | 5.3 Weekly BMs | Standard Deviation 3.15 |
Primary
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat population with evaluable SBM data during the given month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Baseline | 1.4 Weekly SBMs | Standard Deviation 0.98 |
| All Participants | Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Month 1 | 4.9 Weekly SBMs | Standard Deviation 2.72 |
| All Participants | Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Month 2 | 4.9 Weekly SBMs | Standard Deviation 2.62 |
| All Participants | Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Month 3 | 5.0 Weekly SBMs | Standard Deviation 2.76 |
| All Participants | Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Month 4 | 5.0 Weekly SBMs | Standard Deviation 2.71 |
| All Participants | Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Month 5 | 5.0 Weekly SBMs | Standard Deviation 2.82 |
| All Participants | Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Month 6 | 5.0 Weekly SBMs | Standard Deviation 2.86 |
| All Participants | Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Month 7 | 5.1 Weekly SBMs | Standard Deviation 2.93 |
| All Participants | Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Month 8 | 5.3 Weekly SBMs | Standard Deviation 2.91 |
| All Participants | Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | Month 9 | 5.2 Weekly SBMs | Standard Deviation 3.19 |
Secondary
Abdominal Bloating by Month
Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat with evaluable data at the given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Abdominal Bloating by Month | Baseline | 2.2 score on a scale | Standard Deviation 0.74 |
| All Participants | Abdominal Bloating by Month | Month 1 | 1.6 score on a scale | Standard Deviation 0.88 |
| All Participants | Abdominal Bloating by Month | Month 2 | 1.5 score on a scale | Standard Deviation 0.9 |
| All Participants | Abdominal Bloating by Month | Month 3 | 1.5 score on a scale | Standard Deviation 0.91 |
| All Participants | Abdominal Bloating by Month | Month 4 | 1.5 score on a scale | Standard Deviation 0.9 |
| All Participants | Abdominal Bloating by Month | Month 5 | 1.5 score on a scale | Standard Deviation 0.92 |
| All Participants | Abdominal Bloating by Month | Month 6 | 1.5 score on a scale | Standard Deviation 0.91 |
| All Participants | Abdominal Bloating by Month | Month 7 | 1.5 score on a scale | Standard Deviation 0.93 |
| All Participants | Abdominal Bloating by Month | Month 8 | 1.5 score on a scale | Standard Deviation 0.95 |
| All Participants | Abdominal Bloating by Month | Month 9 | 1.5 score on a scale | Standard Deviation 0.95 |
Secondary
Abdominal Discomfort by Month
Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat with evaluable data at the given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Abdominal Discomfort by Month | Baseline | 2.2 score on a scale | Standard Deviation 0.67 |
| All Participants | Abdominal Discomfort by Month | Month 1 | 1.5 score on a scale | Standard Deviation 0.82 |
| All Participants | Abdominal Discomfort by Month | Month 2 | 1.4 score on a scale | Standard Deviation 0.82 |
| All Participants | Abdominal Discomfort by Month | Month 3 | 1.4 score on a scale | Standard Deviation 0.84 |
| All Participants | Abdominal Discomfort by Month | Month 4 | 1.4 score on a scale | Standard Deviation 0.83 |
| All Participants | Abdominal Discomfort by Month | Month 5 | 1.4 score on a scale | Standard Deviation 0.86 |
| All Participants | Abdominal Discomfort by Month | Month 6 | 1.4 score on a scale | Standard Deviation 0.85 |
| All Participants | Abdominal Discomfort by Month | Month 7 | 1.4 score on a scale | Standard Deviation 0.85 |
| All Participants | Abdominal Discomfort by Month | Month 8 | 1.4 score on a scale | Standard Deviation 0.89 |
| All Participants | Abdominal Discomfort by Month | Month 9 | 1.4 score on a scale | Standard Deviation 0.91 |
Secondary
Bowel Habit Regularity by Month
Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular. The highest score is 7, but the best score is 1.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat with evaluable data at the given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Bowel Habit Regularity by Month | Baseline | 4.7 score on a scale | Standard Deviation 1.59 |
| All Participants | Bowel Habit Regularity by Month | Month 1 | 3.6 score on a scale | Standard Deviation 1.39 |
| All Participants | Bowel Habit Regularity by Month | Month 2 | 3.6 score on a scale | Standard Deviation 1.38 |
| All Participants | Bowel Habit Regularity by Month | Month 3 | 3.5 score on a scale | Standard Deviation 1.42 |
| All Participants | Bowel Habit Regularity by Month | Month 4 | 3.5 score on a scale | Standard Deviation 1.45 |
| All Participants | Bowel Habit Regularity by Month | Month 5 | 3.5 score on a scale | Standard Deviation 1.47 |
| All Participants | Bowel Habit Regularity by Month | Month 6 | 3.5 score on a scale | Standard Deviation 1.5 |
| All Participants | Bowel Habit Regularity by Month | Month 7 | 3.5 score on a scale | Standard Deviation 1.47 |
| All Participants | Bowel Habit Regularity by Month | Month 8 | 3.4 score on a scale | Standard Deviation 1.49 |
| All Participants | Bowel Habit Regularity by Month | Month 9 | 3.4 score on a scale | Standard Deviation 1.51 |
Secondary
Constipation Severity by Month
Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat with evaluable scores at the given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Constipation Severity by Month | Baseline | 2.4 score on a scale | Standard Deviation 0.72 |
| All Participants | Constipation Severity by Month | Month 1 | 1.5 score on a scale | Standard Deviation 0.93 |
| All Participants | Constipation Severity by Month | Month 2 | 1.5 score on a scale | Standard Deviation 0.94 |
| All Participants | Constipation Severity by Month | Month 3 | 1.5 score on a scale | Standard Deviation 0.93 |
| All Participants | Constipation Severity by Month | Month 4 | 1.5 score on a scale | Standard Deviation 0.96 |
| All Participants | Constipation Severity by Month | Month 5 | 1.4 score on a scale | Standard Deviation 0.95 |
| All Participants | Constipation Severity by Month | Month 6 | 1.4 score on a scale | Standard Deviation 0.94 |
| All Participants | Constipation Severity by Month | Month 7 | 1.4 score on a scale | Standard Deviation 0.94 |
| All Participants | Constipation Severity by Month | Month 8 | 1.4 score on a scale | Standard Deviation 0.97 |
| All Participants | Constipation Severity by Month | Month 9 | 1.4 score on a scale | Standard Deviation 0.99 |
Secondary
Mean Weekly Complete BMs by Month
Participants rate each BM as complete if their bowels feel completely empty after the BM
Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat with evaluable data at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Weekly Complete BMs by Month | Month 1 | 3.1 Weekly Complete BMs | Standard Deviation 2.26 |
| All Participants | Mean Weekly Complete BMs by Month | Month 2 | 3.4 Weekly Complete BMs | Standard Deviation 2.28 |
| All Participants | Mean Weekly Complete BMs by Month | Month 3 | 3.6 Weekly Complete BMs | Standard Deviation 2.46 |
| All Participants | Mean Weekly Complete BMs by Month | Month 4 | 3.7 Weekly Complete BMs | Standard Deviation 2.38 |
| All Participants | Mean Weekly Complete BMs by Month | Month 5 | 3.8 Weekly Complete BMs | Standard Deviation 2.65 |
| All Participants | Mean Weekly Complete BMs by Month | Month 6 | 3.8 Weekly Complete BMs | Standard Deviation 2.62 |
| All Participants | Mean Weekly Complete BMs by Month | Month 7 | 3.8 Weekly Complete BMs | Standard Deviation 2.78 |
| All Participants | Mean Weekly Complete BMs by Month | Month 8 | 3.9 Weekly Complete BMs | Standard Deviation 2.69 |
| All Participants | Mean Weekly Complete BMs by Month | Month 9 | 4.1 Weekly Complete BMs | Standard Deviation 2.96 |
Secondary
Mean Weekly Complete SBMs by Month
Participants rate each SBM as complete if their bowels feel completely empty after the SBM
Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat with evaluable data at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mean Weekly Complete SBMs by Month | Month 1 | 3.1 Weekly Complete SBMs | Standard Deviation 2.26 |
| All Participants | Mean Weekly Complete SBMs by Month | Month 2 | 3.4 Weekly Complete SBMs | Standard Deviation 2.27 |
| All Participants | Mean Weekly Complete SBMs by Month | Month 3 | 3.6 Weekly Complete SBMs | Standard Deviation 2.47 |
| All Participants | Mean Weekly Complete SBMs by Month | Month 4 | 3.6 Weekly Complete SBMs | Standard Deviation 2.4 |
| All Participants | Mean Weekly Complete SBMs by Month | Month 5 | 3.7 Weekly Complete SBMs | Standard Deviation 2.64 |
| All Participants | Mean Weekly Complete SBMs by Month | Month 6 | 3.7 Weekly Complete SBMs | Standard Deviation 2.62 |
| All Participants | Mean Weekly Complete SBMs by Month | Month 7 | 3.9 Weekly Complete SBMs | Standard Deviation 2.79 |
| All Participants | Mean Weekly Complete SBMs by Month | Month 8 | 3.9 Weekly Complete SBMs | Standard Deviation 2.69 |
| All Participants | Mean Weekly Complete SBMs by Month | Month 9 | 4.2 Weekly Complete SBMs | Standard Deviation 2.95 |
Secondary
Number of Participants Classified as Monthly Responders
A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed). A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.
Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified as Monthly Responders | Month 1 | 322 Participants |
| All Participants | Number of Participants Classified as Monthly Responders | Month 2 | 323 Participants |
| All Participants | Number of Participants Classified as Monthly Responders | Month 3 | 291 Participants |
| All Participants | Number of Participants Classified as Monthly Responders | Month 4 | 270 Participants |
| All Participants | Number of Participants Classified as Monthly Responders | Month 5 | 259 Participants |
| All Participants | Number of Participants Classified as Monthly Responders | Month 6 | 250 Participants |
| All Participants | Number of Participants Classified as Monthly Responders | Month 7 | 239 Participants |
| All Participants | Number of Participants Classified as Monthly Responders | Month 8 | 233 Participants |
| All Participants | Number of Participants Classified as Monthly Responders | Month 9 | 202 Participants |
Secondary
Stool Consistency of Spontaneous Bowel Movements by Month
Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat with evaluable data at the given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Stool Consistency of Spontaneous Bowel Movements by Month | Baseline | 3.0 score on a scale | Standard Deviation 0.84 |
| All Participants | Stool Consistency of Spontaneous Bowel Movements by Month | Month 1 | 2.3 score on a scale | Standard Deviation 0.75 |
| All Participants | Stool Consistency of Spontaneous Bowel Movements by Month | Month 2 | 2.2 score on a scale | Standard Deviation 0.73 |
| All Participants | Stool Consistency of Spontaneous Bowel Movements by Month | Month 3 | 2.2 score on a scale | Standard Deviation 0.74 |
| All Participants | Stool Consistency of Spontaneous Bowel Movements by Month | Month 4 | 2.2 score on a scale | Standard Deviation 0.72 |
| All Participants | Stool Consistency of Spontaneous Bowel Movements by Month | Month 5 | 2.2 score on a scale | Standard Deviation 0.7 |
| All Participants | Stool Consistency of Spontaneous Bowel Movements by Month | Month 6 | 2.2 score on a scale | Standard Deviation 0.68 |
| All Participants | Stool Consistency of Spontaneous Bowel Movements by Month | Month 7 | 2.2 score on a scale | Standard Deviation 0.7 |
| All Participants | Stool Consistency of Spontaneous Bowel Movements by Month | Month 8 | 2.2 score on a scale | Standard Deviation 0.66 |
| All Participants | Stool Consistency of Spontaneous Bowel Movements by Month | Month 9 | 2.2 score on a scale | Standard Deviation 0.7 |
Secondary
Straining Associated With Spontaneous Bowel Movements by Month
Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat with evaluable data at the given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Straining Associated With Spontaneous Bowel Movements by Month | Baseline | 2.7 score on a scale | Standard Deviation 0.87 |
| All Participants | Straining Associated With Spontaneous Bowel Movements by Month | Month 1 | 1.7 score on a scale | Standard Deviation 0.85 |
| All Participants | Straining Associated With Spontaneous Bowel Movements by Month | Month 2 | 1.7 score on a scale | Standard Deviation 0.85 |
| All Participants | Straining Associated With Spontaneous Bowel Movements by Month | Month 3 | 1.6 score on a scale | Standard Deviation 0.84 |
| All Participants | Straining Associated With Spontaneous Bowel Movements by Month | Month 4 | 1.7 score on a scale | Standard Deviation 0.83 |
| All Participants | Straining Associated With Spontaneous Bowel Movements by Month | Month 5 | 1.6 score on a scale | Standard Deviation 0.85 |
| All Participants | Straining Associated With Spontaneous Bowel Movements by Month | Month 6 | 1.7 score on a scale | Standard Deviation 0.84 |
| All Participants | Straining Associated With Spontaneous Bowel Movements by Month | Month 7 | 1.7 score on a scale | Standard Deviation 0.86 |
| All Participants | Straining Associated With Spontaneous Bowel Movements by Month | Month 8 | 1.6 score on a scale | Standard Deviation 0.87 |
| All Participants | Straining Associated With Spontaneous Bowel Movements by Month | Month 9 | 1.6 score on a scale | Standard Deviation 0.92 |
Secondary
Treatment Effectiveness by Month
Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The highest and best score is 4.
Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: Intent-to-treat with evaluable data at the given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Treatment Effectiveness by Month | Month 1 | 2.1 score on a scale | Standard Deviation 0.98 |
| All Participants | Treatment Effectiveness by Month | Month 2 | 2.1 score on a scale | Standard Deviation 1.02 |
| All Participants | Treatment Effectiveness by Month | Month 3 | 2.2 score on a scale | Standard Deviation 1.04 |
| All Participants | Treatment Effectiveness by Month | Month 4 | 2.2 score on a scale | Standard Deviation 1.05 |
| All Participants | Treatment Effectiveness by Month | Month 5 | 2.2 score on a scale | Standard Deviation 1.05 |
| All Participants | Treatment Effectiveness by Month | Month 6 | 2.2 score on a scale | Standard Deviation 1.04 |
| All Participants | Treatment Effectiveness by Month | Month 7 | 2.3 score on a scale | Standard Deviation 1.05 |
| All Participants | Treatment Effectiveness by Month | Month 8 | 2.3 score on a scale | Standard Deviation 1.08 |
| All Participants | Treatment Effectiveness by Month | Month 9 | 2.3 score on a scale | Standard Deviation 1.09 |