Trial · NCT02138747
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT) | Week 8 (End of Period 1) and Week 18 (End of Period 2) | The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects). |
| Secondary | Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | Week 18 (End of Period 2) | Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 ("strong preference for period 1," "mild preference for period 1," "no preference," "mild preference for period 2," "strong preference for period 2"). Participants who selected either a "mild preference" or "strong preference" were considered as having a preference for a specific study drug and participants who selected "no preference" were considered as having no preference for one study drug over the other study drug." |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB. | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control | Week 8 (End of Period 1) and Week 18 (End of Period 2) | OAB control was scored from 0 to 100, with higher scores indicating better OAB control. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations | Week 8 (End of Period 1) and Week 18 (End of Period 2) | The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication. |
| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication | Week 8 (End of Period 1) and Week 18 (End of Period 2) | Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication. |
| Secondary | Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and EOT (Period 1-Week 8 and Period 2- Week 18) | |
| Secondary | Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours | Baseline and EOT (Period 1-Week 8 and Period 2- Week 18) | |
| Secondary | Number of Participants With Adverse Events | Baseline to EOT (Week 18) and follow up (Week 20) | Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests \[LFTs\]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug. |
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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