Trial · NCT02425722
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 in weekly average of SBM frequency | From baseline to week 1 | SBM: Spontaneous Bowel Movement. SBM means the defecation without procedure of laxative, suppository, enema, or stool extraction on the day or preceding day of the defecation. SBM frequency is calculated as follows: (the week total number of SBM )/ (the total number of days on which the frequency of SBM is evaluable) x7 |
| Secondary | Weekly responder rate for SBM | up to 2 weeks | 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 | Weekly responder rate for CSBM | up to 2 weeks | 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 SBM within 24 hours after the start of initial treatment | up to 24 hours | |
| Secondary | Change in weekly average of CSBM frequency | From baseline to week 1 | |
| Secondary | Proportion of subjects with CSBM within 24 hours after the start of initial treatment | up to 24 hours | |
| Secondary | Weekly responder rate of the global assessment of relief of chronic constipation. | up to 2 weeks | 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 the abdominal bowel habits improvement in chronic constipation. | up to 2 weeks | Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2 |
| Secondary | Weekly responder rate of abdominal symptom relief of chronic constipation. | up to 2 weeks | Score of abdominal symptom improvement effect (7 scores: 1-7) is 1 or 2 |
| Secondary | Score of the global assessment of relief of chronic constipation | up to 2 weeks | Scores will be measured using a seven-point ordinal score |
| Secondary | Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales) | Week 0, and 2 | IBS-QOL-J: Irritable bowel syndrome quality of life Japanese version |
| Secondary | Changes in weekly average of SBM frequency | From baseline to every week until 2 weeks | SBM: Spontaneous Bowel Movement |
| Secondary | Changes in weekly average of CSBM frequency | From baseline to every week until 2 weeks | CSBM: Complete Spontaneous Bowel Movement |
| Secondary | Changes in weekly average of stool form | From baseline to every week until 2 weeks | Stool form will be measured using seven-point Bristol Stool Form Scale |
| Secondary | Changes in weekly average of abdominal bloating severity scores | From baseline to every week until 2 weeks | Abdominal bloating severity will be measured using a five-point ordinal score |
| Secondary | Changes in weekly average of abdominal pain/discomfort severity scores | From baseline to every week until 2 weeks | Abdominal pain/discomfort severity will be measured using a five-point ordinal score |
| Secondary | Changes in weekly average of straining severity scores | From baseline to every week until 2 weeks | Straining severity will be measured using a five-point ordinal score |
| Secondary | Score of the abdominal bowel habits improvement in chronic constipation | up to 2 weeks | Scores will be measured using a seven-point ordinal score |
| Secondary | Score of the abdominal symptom relief of chronic constipation | up to 2 weeks | Scores will be measured using a seven-point ordinal score |
| Secondary | Safety assessed by development of incidence of adverse events, vital signs, clinical laboratory tests and body weight | up to 2 weeks |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02425722/registered