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Single dose study to measure blood levels and safety of a drug for children with overactive bladder

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01539707

Astellas Study ID

The unique identification code given by the study sponsor.

905-CL-079

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2011-000250-28

Follow Trial

Condition

Overactive Bladder Disease, Bladder Disease

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

5 years - 17 years

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Mar 2012 - Aug 2012

Masking

None (Open Label)

Enrollment number

14

A Multicenter, Open-label, Single-dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Subjects from 5 to less than 18 years of age with Neurogenic Detrusor Overactivity (NDO)

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site: 3201

Gent, Belgium, 9000

Québec City, Canada, G1V 4G2

Site: 4801

Warszawa, Poland, 04-730

Site: 90

Ankara, Turkey, 6100

Site: 3102

Utrecht, Netherlands, 3584 EA

Site: 4501

Århus N, Denmark, DK-8200

Site: 44

Sheffield, United Kingdom, S10 2TH

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