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A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

NCT01565694 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-11-14

Study results available
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Summary

The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.

Conditions

  • Neurogenic Detrusor Overactivity

Interventions

DRUG

Solifenacin succinate

Oral suspension administered once a day via syringe.

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Clinical Study Manager · Astellas Pharma Europe B.V.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-14
Primary Completion
2016-04-28
Completion
2016-04-28

Countries

  • United States
  • Belgium
  • Brazil
  • Denmark
  • Hungary
  • Mexico
  • Philippines
  • Poland
  • South Korea
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01565694 on ClinicalTrials.gov