A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR) (SOLAR)

September 17, 2014 updated by: Astellas Pharma Inc

Solifenacin Succinate in a Flexible Dose Regimen With Simplified Bladder Training Versus Solifenacin Succinate in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study

This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects are screened between day -14 and day -1.

At day 0 subjects will enter a randomized, parallel group study. After fulfilling all selection criteria, subjects will be randomized to one of two treatment arms, solifenacin 5mg with bladder training or solifenacin 5mg alone. After 8 weeks of treatment subjects will be sub divided; subjects on solifenacin 5mg with bladder training will be given the option to increase dose and be divided into solifenacin 5mg with bladder training or solifenacin 10mg with bladder training. Subjects on solifenacin alone, will also be given the option to increase dose and be divided into solifenacin 5mg alone and solifenacin 10mg alone.

There are 5 visits in total: visit 1(screening), visit 2 (randomisation), visit 3 (week 4), visit 4 (week 8), telephone visit (week 12) and visit 5 (week 16)

All subjects receive medication in the form of solifenacin succinate 5mg tablets (two tablets for 10mg) (Company code: YM905, Company serial number: RVG29151)

Subjects randomized to bladder training will receive a single sheet of instructions for bladder training.

Study Type

Interventional

Enrollment (Actual)

643

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Concord, Australia
      • Parkville, Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
      • Randwick, New South Wales, Australia, 2031
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
    • Victoria
      • Clayton, Victoria, Australia, 3168
  • Belgium
      • Antwerp, Belgium, 2020
      • Brussels, Belgium, 1090
      • Brussels, Belgium, 1200
      • Gent, Belgium, 9000
      • Gent, Belgium
      • Kortrijk, Belgium, 8500
      • La Louviere, Belgium
      • Sint-Truiden, Belgium, 3800
  • Czech Republic
      • Jihlava, Czech Republic, 586 01
      • Liberec, Czech Republic, 460 63
      • Olomouc, Czech Republic, 772 00
      • Plzen, Czech Republic, 326 00
      • Prague, Czech Republic, 147 00
  • France
      • Annecy Cedex, France
      • Arras, France
      • Bordeaux, France
      • Landerneau, France
      • Marseille, France
      • Paris, France
      • Rouen, France
      • Saint Louis Cedex, France
      • Thionville, France
      • Toulouse, France, 31400
      • Valenciennes, France
      • Vernon, France
  • Hungary
      • Budapest, Hungary
      • Budapest, Hungary, H-1145
      • Kecskemet, Hungary
      • Nyiregyhaza, Hungary, H-4400
      • Tatabanya, Hungary
  • Italy
      • Bari, Italy
      • Cinisello Balsamo, Italy
      • Como, Italy
      • Genova, Italy
      • Milan, Italy, 20092
      • Naples, Italy
  • Netherlands
      • Leiden, Netherlands, 2334
      • Roermond, Netherlands, 6043
      • Tilburg, Netherlands, 5022
      • Zwijndrecht, Netherlands, 331
  • Poland
      • Warsaw, Poland, 00-846
      • Warsaw, Poland, 02-520
  • Russian Federation
      • Moscow, Russian Federation, 119049
      • Moscow, Russian Federation, 125206
      • Moscow, Russian Federation, 101000
      • Moscow, Russian Federation, 117815
      • Moscow, Russian Federation, 119415
      • St Petersburg, Russian Federation, 197098
  • Spain
      • Aviles, Spain
      • Burgos, Spain
      • Madrid, Spain
      • Manacor, Spain
      • Marbella, Spain
      • Santander, Spain
      • Santiago de Compostela, Spain
      • Sevilla, Spain
  • Turkey
      • Ankara, Turkey
      • Istanbul, Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for> 3 months

Exclusion Criteria:

  • Clinically significant outflow obstruction
  • Significant post void residual volume
  • Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
  • Patient with a neurological cause for abnormal detrusor activity.
  • Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Solifenacin succinate
Drug: Solifenacin succinate
tablet
Other Names:
  • YM905
Experimental: 2
Solifenacin succinate and simplified bladder training
Behavioral: Simplified bladder training
Instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean number of micturitions per 24 hours after 8 weeks
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean number of micturitions per 24 hours after 16 weeks
Time Frame: 16 weeks
16 weeks
Change from baseline in mean urgency frequency per 24 hours
Time Frame: 8 and 16 weeks
8 and 16 weeks
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
Time Frame: 8 and 16 weeks
8 and 16 weeks
Change from baseline in number of pads used
Time Frame: 8 and 16 weeks
8 and 16 weeks
Incidence and severity of adverse events
Time Frame: 8 and 16 weeks
8 and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Europe B.V.

Investigators

  • Principal Investigator: Astellas Medical Affairs Europe, University Hospital, Lund, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

June 14, 2006

First Submitted That Met QC Criteria

June 15, 2006

First Posted (Estimate)

June 16, 2006

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 905-EC-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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