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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02138747
Other study ID # 178-MA-1001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 24, 2014
Est. completion date November 11, 2015

Study information

Verified date February 2020
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the impact of treatment on micturition frequency and incontinence episodes.


Description:

The study consisted of two double-blind treatment periods with a wash-out period in between.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mirabegron
Oral
Tolterodine ER
Oral

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Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Global Development, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT) 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). Week 8 (End of Period 1) and Week 18 (End of Period 2)
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. 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." Week 18 (End of Period 2)
Secondary Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB. 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. Week 8 (End of Period 1) and Week 18 (End of Period 2)
Secondary Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control OAB control was scored from 0 to 100, with higher scores indicating better OAB control. Week 8 (End of Period 1) and Week 18 (End of Period 2)
Secondary Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control. Week 8 (End of Period 1) and Week 18 (End of Period 2)
Secondary Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations 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. Week 8 (End of Period 1) and Week 18 (End of Period 2)
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 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. Week 8 (End of Period 1) and Week 18 (End of Period 2)
Secondary Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication. Week 8 (End of Period 1) and Week 18 (End of Period 2)
Secondary Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication 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. Week 8 (End of Period 1) and Week 18 (End of Period 2)
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 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. Week 8 (End of Period 1) and Week 18 (End of Period 2)
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 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. Baseline to EOT (Week 18) and follow up (Week 20)
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