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A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients

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ClinicalTrials.gov Identifier: NCT01745094
Recruitment Status : Completed
First Posted : December 7, 2012
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Overactive Bladder
Interventions: Drug: mirabegron
Drug: solifenacin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with overactive bladder (OAB) were enrolled in 29 sites in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Solifenacin 2.5 mg + Mirabegron 25 mg Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
Solifenacin 2.5 mg + Mirabegron 50 mg Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
Solifenacin 5 mg + Mirabegron 25 mg Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
Solifenacin 5 mg + Mirabegron 50 mg Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.

Participant Flow:   Overall Study
    Solifenacin 2.5 mg + Mirabegron 25 mg   Solifenacin 2.5 mg + Mirabegron 50 mg   Solifenacin 5 mg + Mirabegron 25 mg   Solifenacin 5 mg + Mirabegron 50 mg
STARTED   35   37   58   93 
COMPLETED   30   37   46   90 
NOT COMPLETED   5   0   12   3 
Not Meeting the Eligibility Criteria                1                0                3                0 
Adverse Event                0                0                3                0 
Withdrawal by Subject                2                0                1                2 
Protocol Violation                1                0                3                1 
Need Further Examinations Due to Biopsy                0                0                1                0 
Show no Stable Solifenacin Intake                0                0                1                0 
Untenable Due to Recurrent Cystitis                1                0                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Analysis Set (SAF). The SAF consisted of participants who received at least 1 dose of the study drug for the treatment period.

Reporting Groups
  Description
Solifenacin 2.5 mg + Mirabegron 25 mg Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
Solifenacin 2.5 mg + Mirabegron 50 mg Participants received solifenacin 2.5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 2.5 mg, but received an increased dose of mirabegron 50 mg.
Solifenacin 5 mg + Mirabegron 25 mg Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 16 weeks.
Solifenacin 5 mg + Mirabegron 50 mg Participants received solifenacin 5 mg and mirabegron 25 mg once daily after breakfast orally for 8 weeks. In the next 8 weeks, participants continued to receive solifenacin 5 mg, but received an increased dose of mirabegron 50 mg.
Total Total of all reporting groups

Baseline Measures
   Solifenacin 2.5 mg + Mirabegron 25 mg   Solifenacin 2.5 mg + Mirabegron 50 mg   Solifenacin 5 mg + Mirabegron 25 mg   Solifenacin 5 mg + Mirabegron 50 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   37   58   93   223 
Age 
[Units: Years]
Mean (Standard Deviation)
         
Participants Analyzed   35   37   58   93   223 
   65.6  (8.71)   62.8  (10.27)   66.9  (9.47)   63.8  (10.34)   64.7  (9.92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Participants Analyzed   35   37   58   93   223 
Female      30  85.7%      32  86.5%      45  77.6%      79  84.9%      186  83.4% 
Male      5  14.3%      5  13.5%      13  22.4%      14  15.1%      37  16.6% 
Overactive Bladder Symptom Score (OABSS) [1] [2] 
[Units: Units on a Scale]
Mean (Standard Deviation)
         
Participants Analyzed   33   37   55   93   218 
   7.1  (2.31)   8.5  (2.36)   7.5  (2.67)   8.1  (2.45)   7.8  (2.49) 
Overactive Bladder questionnaire Short Form (OAB-q SF) Score: Symptom Severity [1] [2] 
[Units: Units on a Scale]
Mean (Standard Deviation)
         
Participants Analyzed   33   37   55   93   218 
   33.94  (20.386)   39.37  (20.470)   32.12  (17.701)   31.29  (19.205)   33.27  (19.328) 
OAB-q SF Score: Total Health-Related Quality of Life (HRQOL) [1] [2] 
[Units: Units on a Scale]
Mean (Standard Deviation)
         
Participants Analyzed   33   37   55   93   218 
   73.71  (18.662)   70.31  (18.873)   75.10  (17.708)   76.06  (19.341)   74.49  (18.743) 
Number of Micturitions per 24 Hours [1] [2] 
[Units: Micturitions]
Mean (Standard Deviation)
         
Participants Analyzed   33   37   55   93   218 
   10.38  (2.128)   11.12  (2.722)   9.81  (1.918)   10.15  (2.331)   10.26  (2.302) 
Number of Urgency Episodes per 24 Hours [1] [2] 
[Units: Urgency episodes]
Mean (Standard Deviation)
         
Participants Analyzed   30   36   49   90   205 
   2.86  (2.433)   4.12  (2.586)   2.86  (1.997)   3.63  (2.846)   3.42  (2.586) 
Number of Incontinence Episodes per 24 Hours [1] [2] 
[Units: Incontinence episodes]
Mean (Standard Deviation)
         
Participants Analyzed   14   28   29   60   131 
   1.45  (1.454)   1.54  (1.248)   2.09  (2.121)   1.51  (1.520)   1.64  (1.616) 
Number of Urge Incontinence Episodes per 24 Hours [1] [2] 
[Units: Urge incontinence episodes]
Mean (Standard Deviation)
         
Participants Analyzed   11   28   26   52   117 
   1.42  (1.506)   1.42  (1.243)   1.69  (1.366)   1.30  (1.138)   1.43  (1.245) 
Volume Voided per Micturition [1] [2] 
[Units: mL]
Mean (Standard Deviation)
         
Participants Analyzed   33   37   55   93   218 
   158.627  (47.0511)   158.633  (43.6678)   182.362  (56.3405)   173.658  (47.5973)   171.029  (49.7826) 
Number of Nocturia Episodes per Night [1] [2] 
[Units: Nocturia episodes]
Mean (Standard Deviation)
         
Participants Analyzed   28   29   50   81   188 
   1.79  (1.075)   1.55  (0.783)   1.85  (1.006)   1.72  (1.084)   1.74  (1.018) 
Postvoid Residual (PVR) Volume [1] 
[Units: mL]
Mean (Standard Deviation)
         
Participants Analyzed   35   37   58   93   223 
   14.95  (23.214)   10.51  (16.066)   13.93  (17.188)   12.11  (20.199)   12.76  (19.273) 


  Outcome Measures

1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs)   [ Time Frame: From first dose of study drug up to weeks 16 ]

2.  Secondary:   Change From Baseline in OABSS Total Score   [ Time Frame: Baseline and week 8, 16 ]

3.  Secondary:   Number of Participants Who Achieved Normalization for OABSS Total Score   [ Time Frame: Week 8 and 16 ]

4.  Secondary:   Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score   [ Time Frame: Baseline and week 8, 16 ]

5.  Secondary:   Change From Baseline in OAB-q SF Total HRQL Score   [ Time Frame: Baseline and week 8, 16 ]

6.  Secondary:   Change From Baseline in the Number of Micturitions Per 24 Hours   [ Time Frame: Baseline and week 4, 8, 12, 16 ]

7.  Secondary:   Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours   [ Time Frame: Week 16 ]

8.  Secondary:   Change From Baseline in the Number of Urgency Episodes Per 24 Hours   [ Time Frame: Baseline and week 4, 8, 12, 16 ]

9.  Secondary:   Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours   [ Time Frame: Week 16 ]

10.  Secondary:   Change From Baseline in the Number of Incontinence Episodes Per 24 Hours   [ Time Frame: Baseline and week 4, 8, 12, 16 ]

11.  Secondary:   Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours   [ Time Frame: Week 16 ]

12.  Secondary:   Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours   [ Time Frame: Baseline and week 4, 8, 12, 16 ]

13.  Secondary:   Change From Baseline in the Volume Voided Per Micturition   [ Time Frame: Baseline and week 8, 16 ]

14.  Secondary:   Change From Baseline in the Number of Nocturia Episodes Per Night   [ Time Frame: Baseline and week 4, 8, 12, 16 ]

15.  Secondary:   Change From Baseline in Postvoid Residual (PVR) Volume   [ Time Frame: Baseline and week 4, 8, 12, 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Astellas Pharma Inc.
phone: +81-3-3244-0512 Ext:
e-mail: motoko.ida@astellas.com



Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01745094     History of Changes
Other Study ID Numbers: 178-CL-110
First Submitted: December 6, 2012
First Posted: December 7, 2012
Results First Submitted: December 10, 2017
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018