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NCT00337090 Clinical Trial

A Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)

Overactive Bladder Clinical Trial

Official title:
A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Dose Ranging Study With the Beta-3 Agonist YM178 in Patients With Symptomatic Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00337090
Other study ID # 178-CL-044
Secondary ID
Status Completed
Phase Phase 2
First received June 14, 2006
Last updated July 1, 2013
Est. completion date March 2007

Study information
Verified date July 2013
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesHungary: National Institute of PharmacyItaly: The Italian Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Ministry of HealthSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNorway: Norwegian Medicines AgencyRussia: Pharmacological Committee, Ministry of Health
Study type Interventional

Clinical Trial Summary

The study will examine which dose of YM178 is best in terms of efficacy, safety and tolerability compared to placebo and compared to tolterodine, a marketed product.

Recruitment information / eligibility
Status Completed
Enrollment 1108
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients over 18 years suffering from overactive bladder (OAB) for more than 3 months

Exclusion Criteria:

- Pregnant and breastfeeding women

- Any medical condition or need for co-medication which interferes with the drug under investigation (YM178) or the comparator (tolterodine)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• YM178

Locations
Country Name City State
Belgium 3 Sites Antwerp
Belgium 2 Sites Brussels
Czech Republic 3 Sites Prague
France 2 Sites Nantes
France 2 Sites Paris
Greece 3 Sites Athens
Poland 3 Sites Warszawa
Poland 3 Sites Wroclaw
Russian Federation 7 Sites Moscow
Russian Federation 3 Sites St Petersburg
Spain 2 Sites Barcelona
Spain 2 Sites Madrid
Sweden 2 Sites Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

See also
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Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Completed NCT02667470 - Reproducibility Study of OABSS and Its Response to Treatment Phase 4

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