Trial · NCT00601484
Outcomes46
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 46
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Average Daily Pain Score at Week 6 | Baseline, Week 6 | Restricted Full Analysis Set(rFAS): All randomized participants who received at least 1 dose of treatment, completed at least 5 diary days during 7 days prior to randomization, had at least 1 diary day post-randomization, and who provided baseline and post-randomization primary efficacy data for 4 or more days within the predefined diary windows. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16 | Baseline, Week 2, 4, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | percent change | MEAN |
| SECONDARY | Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | RFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | percent change | MEAN |
| SECONDARY | Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | micturitions per 24 hours | MEAN |
| SECONDARY | Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | micturitions per night | MEAN |
| SECONDARY | Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | episodes per 24 hours | MEAN |
| SECONDARY | Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'overall number of participants analyzed' = participants evaluable and had data available for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | milliliter (mL)/micturition | MEAN |
| SECONDARY | Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | percent change | MEAN |
| SECONDARY | Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here 'number analyzed' signifies those participants who were evaluable for each specified time points. | percent change | MEAN |
| SECONDARY | Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | episodes per 24 hours | MEAN |
| SECONDARY | Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'Number analyzed' = participants with available data for each specified category. | units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | percent change | MEAN |
| SECONDARY | Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16 | Baseline, Week 2, 4, 6, 10, 16 | rFAS population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | units on a scale | MEAN |
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.
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