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Phase 3 N=189 Randomized Quadruple-blind Treatment

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

Urinary Bladder, Overactive

Bottom Line

View on ClinicalTrials.gov: NCT01565707 ↗
Enrolled (actual)
189
Serious AEs
3.2%
Results posted
Jan 2017
Primary outcome: Primary: Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition — 13.4; 25.5; 6.9; 2.3 mL — p=0.046

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Solifenacin Succinate Suspension (Drug); Placebo (Drug); Urotherapy (Behavioral)
Age
Pediatric · 5+ yrs
Sex
All
Sponsor
Astellas Pharma Europe B.V.
Primary completion
Dec 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition		 13.4; 25.5; 6.9; 2.3 0.046 sig
SECONDARY
Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition		 11.3; 43.2; -8.4; -25.7 0.024 sig
SECONDARY
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours		 -1.2; -1.1; -0.7; -0.6 0.763
SECONDARY
Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours		 -1.1; -1.2; -0.2; -0.8 0.402
SECONDARY
Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours		 -0.2; -0.1; -0.2; -0.2 0.630
SECONDARY
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days		 1.7; 1.3; 1.5; 1.6 0.563
SECONDARY
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days		 0.7; 0.4; -0.1; 0.4 0.770
SECONDARY
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours		 -0.8; -1.1; -0.6; -0.4 0.303
SECONDARY
Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours		 -1.1; -1.2; -0.5; -0.3 0.640
SECONDARY
Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours		 0.0; -0.1; 0.4; 0.1 0.846
SECONDARY
Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents		 -0.7; -1.0 —
SECONDARY
Maximum Concentration (Cmax) of Solifenacin		 16.67; 26.24; 17.08; 33.48; 42.85 —
SECONDARY
Time to Attain Maximum Concentration (Tmax) of Solifenacin		 2.933; 3.175; 2.8; 2.874; 2.85 —
SECONDARY
Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin		 9.534; 16.1; 8.828; 19.05; 27.94 —
SECONDARY
Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin		 298.7; 452.8; 269.2; 560; 745.7 —
SECONDARY
Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin		 27.3; 30.98; 24.84; 26.85; 41.27 —
SECONDARY
Apparent Total Body Clearance (CL/F) of Solifenacin		 6.968; 7.608; 14.56; 8.773; 11.3 —
SECONDARY
Apparent Volume of Distribution (Vz/F) of Solifenacin		 272.4; 329.5; 521.9; 315.7; 561.7 —
SECONDARY
Number of Participants With Adverse Events (AEs)		 45; 44; 12; 9; 9; 14 —
SECONDARY
Change From Baseline in Post Void Residual (PVR) Volume		 0.07; -0.99; -3.58; 0.95 —

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01565707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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