Trial · NCT00380250
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Responder Rate | 12 weeks | Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. Overall responder: responder for at least 2/3 months |
| Secondary | Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline | Change from baseline for month 1 | SBMs are any bowel movement not associated with rescue medication use. |
| Secondary | Month 1 Stool Consistency Change From Baseline | Change from baseline for month 1 | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) |
| Secondary | Month 1 Bowel Straining Change From Baseline | Change from baseline for month 1 | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Secondary | Month 1 Constipation Severity Change From Baseline | Change from baseline at 28 days | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Secondary | Month 1 Symptom Relief | Change from baseline for month 1 | Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3 |
| Secondary | Quality of Life Change From Baseline | Change from baseline at 12 weeks | Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase |
| Secondary | Month 2 Responder Rate | month 2 (28 days) | Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. |
| Secondary | Month 3 Responder Rate | month 3 (28 days) | Symptoms \>= Moderately relieved for 4 weeks/month or Significantly relieved for \>=2 weeks/month AND: 1. Rescue medication use does not increase during the month as compared to baseline; 2. No discontinuation during the month due to lack of efficacy;AND 3. No ratings during the month of Moderately worse or Significantly worse. |
| Secondary | Month 1 Responder Rate | month 1 (28 days) | Symptoms \>= Moderately relieved for 4 weeks/month or Significantly relieved for \>=2 weeks/month AND: 1. Rescue medication use does not increase during the month as compared to baseline; 2. No discontinuation during the month due to lack of efficacy;AND 3. No ratings during the month of Moderately worse or Significantly worse. |
| Secondary | Month 2 Abdominal Bloating Change From Baseline | Change from baseline for month 2 | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Secondary | Month 3 Abdominal Bloating Change From Baseline | Change from baseline for month 3 | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Secondary | Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline | Change from baseline for month 2 | Any bowel movement not associated with rescue medication use |
| Secondary | Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline | Change from baseline for month 3 | Any bowel movement not associated with rescue medication use |
| Secondary | Month 2 Stool Consistency Change From Baseline | Change from baseline for month 2 | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) |
| Secondary | Month 3 Stool Consistency Change From Baseline | Change from baseline for month 3 | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) |
| Secondary | Month 2 Bowel Straining Change From Baseline | Change from baseline for month 2 | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Secondary | Month 3 Bowel Straining Change From Baseline | Change from baseline for month 3 | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Secondary | Month 2 Constipation Severity Change From Baseline | Change from baseline for month 2 | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Secondary | Month 3 Constipation Severity Change From Baseline | Change from baseline for month 3 | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
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/NCT00380250/registered