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
Intervention: Solifenacin Succinate Suspension; Placebo; Urotherapy
Intervention description: 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.
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric; Solifenacin succinate suspension; Phase 3; Pharmacokinetics; Overactive bladder (OAB)

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.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Written Informed Consent has been obtained

          -  OAB (symptoms of urgency) according to International Children's Continence Society
             (ICCS) criteria

          -  Daytime incontinence with at least 4 or more episodes of incontinence confirmed by 7
             day participant diary

        Main Exclusion Criteria:

          -  Daily voiding frequency less than 5

          -  Extraordinary daytime urinary frequency according to the International Children's
             Continence Society (ICCS) definition

          -  Uroflow indicative of pathology other than OAB

          -  Maximum voided volume (morning volume excluded) > expected bladder capacity for age
             [(age +1) x 30] in ml or a maximum voided volume (morning volume excluded) above 390
             ml

          -  Post Void Residual (PVR) > 20 ml

          -  Monosymptomatic enuresis

          -  Polyuria defined as > 75 ml/kg/b.w./24 hours

          -  Dysfunctional voiding

          -  Congenital anomalies affecting lower urinary tract function

          -  Current constipation

          -  Current Urinary Tract Infection (UTI)

          -  Catheterization within 2 weeks prior to screening