Trial · NCT02751931
Outcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 24 | Baseline and week 24 | The analysis population consisted of the full analysis set (FAS) which included all participants who took ≥ 1 dose of study drug and provided both valid (as by the central reviewer's assessment) nonmissing MCC measurements at baseline and at a postbaseline visit for the primary efficacy endpoint. | mL | MEAN |
| SECONDARY | Change From Baseline in Bladder Compliance (ΔV/ΔP) | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL/cm H2O | MEAN |
| SECONDARY | Change From Baseline in Maximum Cystometric Capacity at Week 4 | Baseline and week 4 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies those who where evaluable for this outcome measure. | mL | MEAN |
| SECONDARY | Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cm H20) Until End of Filling | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | overactive detrusor contractions | MEAN |
| SECONDARY | Change From Baseline in Detrusor Pressure at End of Filling | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | cm H2O | MEAN |
| SECONDARY | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20) | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEDIAN |
| SECONDARY | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Wilcoxon Signed-rank Test Updated Analysis | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEDIAN |
| SECONDARY | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Paired T-test | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEAN |
| SECONDARY | Change From Baseline in Average Catheterized Volume Per Catheterization | Baseline and weeks 2, 4, 8, 12, 24, 36 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEAN |
| SECONDARY | Change From Baseline in Maximum Catheterized Volume | Baseline and weeks 2, 4, 8, 12, 24, 36 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEAN |
| SECONDARY | Change From Baseline in Maximum Catheterized Daytime Volume (MCDV) | Baseline and weeks 2, 4, 8, 12, 24, 36 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEAN |
| SECONDARY | Change From Baseline in Average Morning Catheterized Volume | Baseline and weeks 2, 4, 8, 12, 24, 36 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Leakage Episodes Per Day | Baseline and weeks 2, 4, 8, 12, 24, 36 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | leakage episodes per day | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Leakage Episodes Per Day: Updated Analysis | Baseline and weeks 2, 4, 8, 12, 24, 36 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | leakage episodes per day | MEAN |
| SECONDARY | Change From Baseline in Number of Dry Days Per 7 Days (Day and Night Time) | Baseline and weeks 2, 4, 8, 12, 24, 36 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | dry days per 7 days | MEAN |
| SECONDARY | Change From Baseline in Pediatric Incontinence Questionnaire (PIN-Q) Score | Baseline and weeks 24 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient Global Impression of Severity Scale (PGI-S) | Baseline and weeks 24 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Clinician Global Impression of Change (CGI-C) | Weeks 24 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Study Drug Acceptability for Tablets at Week 4 | Week 4 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Study Drug Acceptability for Tablets at Week 24 | Week 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
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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