Trial · NCT00421707
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Average Adequate Relief Rate During the Last 4 Weeks of the Treatment Periods (Weeks 3-6. in Period 1, Weeks 12-15 in Period 2). | Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2) | Intent to Treat population comprised of all participants who were randomized to treatment, who received at least one dose of double blind medication and for whom at least one valid post baseline efficacy assessment was available. | ||
| PRIMARY | Number of Participants With Changes in Weekly Adequate Relief Rates During the Treatment Periods (Weeks 1-6 in Period 1 and Weeks 9-15 in Period 2). | Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2). | Intent to Treat population. | ||
| PRIMARY | Number of Participants With Adequate Relief of IBS Pain and Discomfort on All 4 of the Last 4 Weeks of the Treatment Phase Treatment Periods 1 and 2 | Up to Day 105 | Intent to Treat population | ||
| PRIMARY | Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Proportion of participants responded | MEAN |
| PRIMARY | Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Score on a scale | MEAN |
| SECONDARY | Number of Participants With Improvements in Pain and Discomfort | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Pain Severity Scores | Baseline (Day 1) and up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Score on a scale | MEAN |
| SECONDARY | Percentages of Pain-free Days | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Intent to Treat population. Only those participants available at the specified time points were analyzed. Washout period was of 3 weeks only. Thus, these categories are not applicable for placebo washout arm. | Percentage of days | MEAN |
| SECONDARY | Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Intent to Treat population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentrations of GW876008 at Week 3 and 6 | Week 3 and 6 visits. Pre-dose [after the pre Electrocardiogram (ECG) measurement and just before am dose] and immediately following the 1-3 hour post-dose ECG measurement | Pharmacokinetic concentration population comprised of all participants for whom a pharmacokinetic sample was obtained and analyzed was included. Only those participants available at the specified time points were analyzed. | ng/mL | MEAN |
| SECONDARY | IBS Composite Symptom Score | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | |||
| SECONDARY | Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Intent to Treat population. Only those participants available at the specified time points were analyzed. | Score on a scale | MEAN |
| SECONDARY | Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD) | Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2) | Intent to Treat population. Only those participants available at the specified time points were analyzed. Washout period was of 3 weeks only. Thus, these categories are not applicable for placebo washout arm. | Score on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT00421707/outcomes