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
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 11/18/2018 |
| Start Date: | October 4, 2012 |
| End Date: | October 8, 2014 |
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)
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).
treating children or adolescents with symptoms of overactive bladder (OAB), who completed
study 905-CL-076 (NCT01565707).
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.
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.
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
We found this trial at
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