Trial · NCT02809105
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in weekly mean SBM frequency during one week of administration (Part I) | Baseline and Week 1 | SBM: Spontaneous bowel movement |
| Secondary | Change from baseline in weekly mean SBM frequency | Baseline and up to Week 56 | |
| Secondary | Weekly responder rate of SBM | Baseline and up to Week 56 | The weekly average value of SBM frequency is more than 3 and over 1 more than the weekly mean value of SBM frequency in the bowel habit observation period. |
| Secondary | Percentage of subjects with SBM within 24 hours after the start of the initial administration | Up to 24h | |
| Secondary | Time to first SBM | Up to Week 4 | |
| Secondary | Change from baseline in weekly mean CSBM frequency | Baseline and up to Week 56 | CSBM: SBM without a sensation of incomplete evacuation |
| Secondary | Weekly responder rate of CSBM | Baseline and up to Week 56 | The weekly average value of CSBM frequency is more than 3 and over 1 more than the weekly mean value of CSBM frequency in the bowel habit observation period. |
| Secondary | Percentage of subjects with CSBM within 24 hours after the start of the initial administration | Up to 24h | |
| Secondary | Change from baseline in weekly mean stool form score | Baseline and up to Week 56 | Stool form will be measured using seven-point Bristol Stool Form Scale. |
| Secondary | Change from baseline in weekly mean abdominal bloating severity score | Baseline and up to Week 56 | Abdominal bloating severity will be measured using a five-point ordinal score. |
| Secondary | Change from baseline in weekly mean abdominal pain/discomfort severity score | Baseline and up to Week 56 | Abdominal pain/discomfort severity will be measured using a five-point ordinal score. |
| Secondary | Change from baseline in weekly mean straining severity score | Baseline and up to Week 56 | Straining severity will be measured using a five-point ordinal score. |
| Secondary | Weekly responder rate of global assessment of relief of CC symptoms | Up to Week 56 | CC: chronic constipation; The weekly responder of the evaluation items shall be the subject satisfying the following at the time of evaluation in each week: Score of Global assessment of relief of chronic constipation symptoms (7 scores: 1-7) is 1 or 2. |
| Secondary | Weekly responder rate of abnormal bowel habits improvement in CC | Up to Week 56 | Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2. |
| Secondary | Weekly responder rate of abdominal symptoms relief of CC | Up to Week 56 | Score of abdominal symptom improvement effect (7 scores: 1-7) is 1 or 2. |
| Secondary | Change from baseline in IBS-QOL-J score | Baseline and up to Week 56 | IBS-QOL-J: Japanese version of Irritable Bowel Syndrome Quality of Life |
| Secondary | Safety assessed by incidence of adverse events | Up to Week 56 | |
| Secondary | Number of participants with abnormal Vital signs and/or adverse events during treatment period | Up to Week 56 | |
| Secondary | Number of participants with abnormal Laboratory values and/or adverse events during treatment period | Up to Week 56 | |
| Secondary | Safety assessed by body weight | Up to Week 56 |
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
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GET https://conductscience.org/api/trials/v1/NCT02809105/registered