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A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)

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.
NCT01981954

Astellas Study ID

The unique identification code given by the study sponsor.

905-CL-074

EudraCT ID

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

2012-003178-22

Follow Trial

Condition

Bladder Disease, Other

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

6 months - 4 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

Sep 2013 - Dec 2015

Masking

None (Open Label)

Enrollment number

23

A Phase 3, Open-Label, Baseline-controlled, Multi-center, Sequential Dose-Titration Study to Assess the Pharmacokinetics, Long-Term Efficacy and Safety of Solifenacin Succinate Suspension in Children From 6 Months to Less Than 5 Years of Age With Neurogenic Detrusor Overactivity

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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Would you like more information about clinical trial sites that are recruiting participants for A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)? Contact us by filling our your information to the right and we’ll respond to you.

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Locations

Site PL4803 Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 81-211

Site DE4911 Universitatsklinikum Schleswig-Holstein Campus Kiel Apotheke

Kiel, Germany, 24105

Site PL4801 Pomnik-Centrum Zdrowia Dziecka

Warszawa, Poland, 04-730

Site US1007 Stanford University Medical Center

Stanford, United States, 94305

Site US1015 The Urological Institute of Northeastern New York

Albany, United States, 12208

Site NL3103 Erasmus MC

Rotterdam, Netherlands, 3015 GJ

Site PH6301 Philippines Children's Medical Center

Manila, Philippines, 1015

Site DK4501 Skejby Sygehus

Arhus N, Denmark, DK-8200

Site FR3301 Groupe Hospitalier Necker - Enfants Malades

Paris, France, 75015

Site KR8207 Seoul National University Hospital

Seoul, Republic of Korea, 110744

Site US1010 Cincinnati Children's Hospital Medical Center

Cincinnati, United States, 45229

Site NL3101 Radboudumc

Nijmegen, Netherlands, 6525 GA

Site KR8201 Severance Hospital

Seoul, Republic of Korea, 120752

Site US1008 Pediatric Urology Associates, P.C.

Tarrytown, United States, 10591

Site PL4802 Samodzielny Publiczny Szpital Kliniczny

Wroclaw, Poland, 50-369

Site BE3203 Gent University Hospital

Gent, Belgium, 9000

Site GB4401 Sheffield Children's Hospital

Sheffield, United Kingdom, S10 2TN

Site DE4905 Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany, 55131

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