Clinical trial NCT01655069: A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
Official title: An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects With Overactive Bladder (OAB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Overactive
Keywords: Overactive bladder (OAB)
Solifenacin succinate suspension
Phase 3
Pediatric
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-08-01
Enrollment: 148
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).

Detailed description: There was a titration period of up to 12 weeks during which the participants would be up or down-titrated based on a combination of efficacy and safety parameters followed by a fixed dose period during which no dose adjustments were allowed. Participants completed a 7-day patient diary prior to every visit (start of 905-CL-076 to end of 905-CL-077, 14 visits). The first visit of this study (905-CL-077) was combined with the last visit of the 4-month study 905-CL-076. At each visit, the participant was required to undertake a number of assessments or examinations to determine whether it is safe for him/her to take part or to continue to take part in the study.

Eligibility criteria: Inclusion Criteria:

* Subject has met the inclusion criteria of study 905-CL-076 and completed study 905-CL-076

Exclusion Criteria:

* Subject has failed the exclusion criteria of study 905-CL-076

Primary outcomes:
measure: Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).
Secondary outcomes:
measure: Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
measure: Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days
timeFrame: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
measure: Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents
timeFrame: Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
measure: Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume
timeFrame: Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Site: 1006
state: Louisiana
city: Antwerp
country: Belgium
facility: Site: 3202
city: Antwerp
country: Belgium
facility: Site: 3209
city: Charleroi
country: Belgium
facility: Site: 3208
city: Gent
country: Belgium
facility: Site: 3201
city: Gent
country: Belgium
facility: Site: 3203
city: Kortrijk
country: Belgium
facility: Site: 3204
city: Leuven
country: Belgium
facility: Site: 3205
city: Campinas
country: Brazil
facility: Site: 5507
city: Curitiba
country: Brazil
facility: Site: 5506
city: Quebec
country: Canada
facility: Site: 1001
city: Aalborg
country: Denmark
facility: Site: 4503
city: Aarhus N
country: Denmark
facility: Site: 4501
city: Koge
country: Denmark
facility: Site: 4504
city: Kolding
country: Denmark
facility: Site: 4502
city: Belgrade
country: Former Serbia and Montenegro
facility: Site: 3810
city: Novi Sad
country: Former Serbia and Montenegro
facility: Site: 3812
city: Daegu
country: Korea, Republic of
facility: Site: 8203
city: Incheon
country: Korea, Republic of
facility: Site: 8206
city: Seoul
country: Korea, Republic of
facility: Site: 8207
city: Seoul
country: Korea, Republic of
facility: Site: 8202
city: Mexico City
country: Mexico
facility: Site: 5202
city: Mexico City
country: Mexico
facility: Site: 5205
city: Bergen
country: Norway
facility: Site: 4701
city: Quezon City
country: Philippines
facility: Site: 6301
city: Gdansk
country: Poland
facility: Site: 4805
city: Gdansk
country: Poland
facility: Site: 4803
city: Lubin
country: Poland
facility: Site: 4804
city: Warsaw
country: Poland
facility: Site: 4801
city: Cape Town
country: South Africa
facility: Site: 2703
city: Gothenburg
country: Sweden
facility: Site: 4606
city: Skovde
country: Sweden
facility: Site: 4603
city: Stockholm
country: Sweden
facility: Site: 4602
city: Umea
country: Sweden
facility: Site: 4605
city: Ankara
country: Turkey
facility: Site: 9001
city: Izmir
country: Turkey
facility: Site: 9002
city: Kharkiv
country: Ukraine
facility: Site: 3854
city: Leeds
country: United Kingdom
facility: Site: 4403
city: Sheffield
country: United Kingdom
facility: Site: 4401
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Clinical Study Manager
role: STUDY_CHAIR
References: