A Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)
This study has been completed.
Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma Europe BV
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00337090
First received: June 14, 2006
Last updated: April 15, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder |
Drug: YM178 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Further study details as provided by Astellas Pharma Inc:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337090
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| Belgium | |
| 3 Sites | |
| Antwerp, Belgium | |
| 2 Sites | |
| Brussels, Belgium | |
| Gent, Belgium | |
| Leuven, Belgium | |
| Liege, Belgium | |
| Czech Republic | |
| Brno, Czech Republic | |
| Melnik, Czech Republic | |
| Ostrava, Czech Republic | |
| 3 Sites | |
| Prague, Czech Republic | |
| Usti nad Labem, Czech Republic | |
| Zlin, Czech Republic | |
| Denmark | |
| Holbaek, Denmark | |
| Kolding, Denmark | |
| Roskilde, Denmark | |
| France | |
| 2 Sites | |
| Nantes, France | |
| 2 Sites | |
| Paris, France | |
| Germany | |
| Bad Ems, Germany | |
| Bamberg, Germany | |
| Bautzen, Germany | |
| Berlin, Germany | |
| Dresden, Germany | |
| Frankfurt, Germany | |
| Hagenow, Germany | |
| Halle/Saale, Germany | |
| Hamburg, Germany | |
| Koblenz, Germany | |
| Leipzig, Germany | |
| Munchen, Germany | |
| Radebeul, Germany | |
| Trier, Germany | |
| Uetersen, Germany | |
| Greece | |
| 3 Sites | |
| Athens, Greece | |
| Patras, Greece | |
| Hungary | |
| Miskolc, Hungary | |
| Nyiregyhaza, Hungary | |
| Pecs, Hungary | |
| Sopron, Hungary | |
| Szeged, Hungary | |
| Tatabanya, Hungary | |
| Italy | |
| Catanzaro, Italy | |
| Milano, Italy | |
| Modena, Italy | |
| Padova, Italy | |
| Roma, Italy | |
| Sassari, Italy | |
| Torino, Italy | |
| Udine, Italy | |
| Varese, Italy | |
| Netherlands | |
| Amsterdam, Netherlands | |
| Apeldoorn, Netherlands | |
| Arnhem, Netherlands | |
| Eindhoven, Netherlands | |
| Enschede, Netherlands | |
| Maastricht, Netherlands | |
| Norway | |
| Bergen, Norway | |
| Oslo, Norway | |
| Tonsberg, Norway | |
| Poland | |
| Bialystok, Poland | |
| Katowice, Poland | |
| Kielce, Poland | |
| Lublin, Poland | |
| 3 Sites | |
| Warszawa, Poland | |
| 3 Sites | |
| Wroclaw, Poland | |
| Russian Federation | |
| 7 Sites | |
| Moscow, Russian Federation | |
| 3 Sites | |
| St Petersburg, Russian Federation | |
| Spain | |
| 2 Sites | |
| Barcelona, Spain | |
| Bilbao, Spain | |
| 2 Sites | |
| Madrid, Spain | |
| Manacor, Spain | |
| Miranda de Ebro, Spain | |
| San Juan de Alica, Spain | |
| Sevilla, Spain | |
| Vigo, Spain | |
| Sweden | |
| Gothenburg, Sweden | |
| 2 Sites | |
| Stockholm, Sweden | |
| United Kingdom | |
| Birmingham, United Kingdom | |
| Blackburn, United Kingdom | |
| Chichester, United Kingdom | |
| Croydon, United Kingdom | |
| London, United Kingdom | |
| Reading, United Kingdom | |
| Sheffield, United Kingdom | |
| Southampton, United Kingdom | |
| Swansea, United Kingdom | |
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe BV
Investigators
| Study Chair: | Astellas Pharma | Astellas Pharma Europe BV |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00337090 History of Changes |
| Other Study ID Numbers: | 178-CL-044 |
| Study First Received: | June 14, 2006 |
| Last Updated: | April 15, 2008 |
| Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Hungary: National Institute of Pharmacy Italy: The Italian Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Ministry of Health Spain: Spanish Agency of Medicines Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency Norway: Norwegian Medicines Agency Russia: Pharmacological Committee, Ministry of Health |
Keywords provided by Astellas Pharma Inc:
|
Over Active Bladder Urinary incontinence YM178 Symptomatic Over Active Bladder |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013