Trial · NCT00620061
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00620061/registered