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

Urinary Bladder, Overactive Clinical Trial

— LEOPARD  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655069
• Other study ID #: 905-CL-077
• Secondary ID: 2011-002047-10
• Status: Completed
• Phase: Phase 3
• Start date: October 4, 2012
• Est. completion date: October 8, 2014

Study information

• Verified date: October 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: October 8, 2014
• Est. primary completion date: October 8, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin succinate suspension
Oral suspension

Locations

Country	Name	City	State
Belgium	Site: 3202	Antwerp
Belgium	Site: 3209	Antwerp
Belgium	Site: 3208	Charleroi
Belgium	Site: 3201	Gent
Belgium	Site: 3203	Gent
Belgium	Site: 3204	Kortrijk
Belgium	Site: 3205	Leuven
Brazil	Site: 5507	Campinas
Brazil	Site: 5506	Curitiba
Canada	Site: 1001	Quebec
Denmark	Site: 4503	Aalborg
Denmark	Site: 4501	Aarhus N
Denmark	Site: 4504	Koge
Denmark	Site: 4502	Kolding
Former Serbia and Montenegro	Site: 3810	Belgrade
Former Serbia and Montenegro	Site: 3812	Novi Sad
Korea, Republic of	Site: 8203	Daegu
Korea, Republic of	Site: 8206	Incheon
Korea, Republic of	Site: 8202	Seoul
Korea, Republic of	Site: 8207	Seoul
Mexico	Site: 5202	Mexico City
Mexico	Site: 5205	Mexico City
Norway	Site: 4701	Bergen
Philippines	Site: 6301	Quezon City
Poland	Site: 4803	Gdansk
Poland	Site: 4805	Gdansk
Poland	Site: 4804	Lubin
Poland	Site: 4801	Warsaw
South Africa	Site: 2703	Cape Town
Sweden	Site: 4606	Gothenburg
Sweden	Site: 4603	Skovde
Sweden	Site: 4602	Stockholm
Sweden	Site: 4605	Umea
Turkey	Site: 9001	Ankara
Turkey	Site: 9002	Izmir
Ukraine	Site: 3854	Kharkiv
United Kingdom	Site: 4403	Leeds
United Kingdom	Site: 4401	Sheffield
United States	Site: 1006	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Denmark,  Former Serbia and Montenegro,  Korea, Republic of,  Mexico,  Norway,  Philippines,  Poland,  South Africa,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)	The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077.	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	Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours	The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.	Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Secondary	Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days	The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.	Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Secondary	Change From Baseline in Mean Number of Micturitions Per 24 Hours	The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.	Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Secondary	Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents	Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.	Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Secondary	Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume	PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks.	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.)

External Links

•   Link to results on EudraCT
•   Link to results on the Astellas Clinical Study Results website