A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      Solifenacin succinate as a tablet formulation is already on the market for the treatment of
      symptoms of overactive bladder in adults. For the use in children and adolescent patients a
      new formulation of solifenacin has been developed.

      This study investigated the effect and safety of solifenacin succinate liquid suspension
      compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the
      double blind period was a single-blind placebo run-in period in combination with behavioral
      urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder
      (OAB) information, awareness, instruction, life-style advice and documentation of voiding
      habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also
      investigated how well solifenacin succinate suspension is taken-up by the body and how long
      it stays in the body during this time.
    


Intervention name(s): Solifenacin Succinate Suspension; Placebo; Urotherapy
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Children aged 5 to 11 years and adolescents aged 12 to 17 years received solifenacin succinate liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary.; Children aged 5 to 11 years and adolescents aged 12 to 17 years received matching placebo liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary.; Non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB.
Other intervention name(s): YM905; Bladder training
Intervention MeSH terms: Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric; Solifenacin succinate suspension; Phase 3; Pharmacokinetics; Overactive bladder (OAB)