Trial · NCT01638000
Outcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 47
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours | Baseline and final visit (up to Week 12) | Per Protocol Set (PPS) - all randomized participants who took ≥1 dose of double-blind study drug and who recorded ≥1 micturition in the baseline diary and ≥1 micturition in a post-baseline diary who had completed the study with no major protocol violations which could impact the primary endpoint. Last observation carried forward (LOCF) was used. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period | From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) | SAF population | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | Full Analysis Set (FAS) - consisted of all randomized participants who took ≥ 1 dose of double-blind study drug and who recorded ≥1 micturition measurement in the baseline diary and ≥1 micturition measurement in a post-baseline diary. N is the number of participants with available data at each time point. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | FAS-Incontinence (FAS-I) - consisted of all FAS participants with ≥1 incontinence episode at baseline. LOCF was used for final visit only. N is the number of participants with available data at each time point. | incontinence episodes | MEAN |
| SECONDARY | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | FAS-I population. N is the number of participants with available data at each time point. | incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | FAS-I population. LOCF was used for final visit only. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point. | urgency incontinence episodes | MEAN |
| SECONDARY | Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | FAS-I population. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point. | urgency incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours | Baseline and Week 4, Week 8, Week 12 | FAS population. LOCF was used for final visit only. Only participants with at least one urgency episode (grade 3 or 4) at baseline were included in this analysis. N is the number of participants with available data at each time point. | urgency episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency | Baseline and Week 4, Week 8, Week 12 | FAS population. LOCF was used in final visit only. N is the number of participants with available data at each time point. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | FAS population. LOCF was used in final visit only. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point. | pads | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Baseline and Week 4, Week 8 , Week 12 | FAS population. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point. | pads | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit | Week 4, Week 8, Week 12 | FAS population. LOCF was used for final visit only. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point. | nocturia episodes | MEAN |
| SECONDARY | Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment | Baseline and Week 4, Week 8, Week 12 | FAS population. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point. | nocturia episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit | Week 4, Week 8, Week 12 | FAS population. LOCF was used for final visit only. N is the number of participants with available data at each timepoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 4, Week 8, Week 12 | FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit | Week 4, Week 8, Week 12 | FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire | Baseline and Week 4 | FAS population who have non-missing values at both Baseline and specified visit. | participants | NUMBER |
| SECONDARY | Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 4 | FAS population who has non-missing values at both Baseline and specified visit. | participants | NUMBER |
| SECONDARY | Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 4 | FAS population who has non-missing values at both Baseline and specified visit. | participants | NUMBER |
| SECONDARY | Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire | Baseline and Week 4 | FAS population who has non-missing values at both Baseline and specified visit. | participants | NUMBER |
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.
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GET https://conductscience.org/api/trials/v1/NCT01638000/outcomes