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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.)
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