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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00578097 |
The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.
Condition | Intervention | Phase |
---|---|---|
Overactive Bladder |
Drug: Botulinum type A (Dysport®) Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, International, Multi-Centre, Prospective, Randomised, Parallel-Group, Double-Blind, Dose-Ranging, Placebo-Controlled, 12-Week, Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-Month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder. |
Estimated Enrollment: | 80 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A - 125 units: Experimental |
Drug: Botulinum type A (Dysport®)
Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
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B - 250 units: Experimental |
Drug: Botulinum type A (Dysport®)
Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
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C - 500 units: Experimental |
Drug: Botulinum type A (Dysport®)
Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
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D: Placebo Comparator |
Other: Placebo
Single injection cycle, intradetrusor injection at baseline (visit 2).
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
UZ Gasthuisberg | |
Leuven, Belgium, 3000 | |
CH Régional Huy - Polyclinique A Rue Trois Ponts | |
Huy, Belgium, 2 4500 | |
ULB Hôpital Erasme | |
Brussels, Belgium, B-1070 | |
CHU Liege Sart Tilman | |
Liege, Belgium | |
Czech Republic | |
Urologické oddělení | |
Praha 4, Czech Republic, 140 00 | |
Urologická klinika | |
Olomouc, Czech Republic, 775 20 | |
France | |
Hôpital Charles Nicolle - CHU de Rouen | |
Rouen Cedex, France, 76031 | |
Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon | |
Saint Genis Laval, France, 69230 | |
Hôpital Michallon - CHU de Grenoble | |
Grenoble Cedex, France, 38043 | |
Hôpital Rangueil - CHU de Toulouse | |
Toulouse, France, 31059 | |
Groupe Hospitalier Pitié-Salpétrière | |
Paris Cedex 16, France, 75661 | |
Germany | |
Praxis für Urologie | |
Emmendingen, Germany, 79312 | |
Städtisches Klinikum Neunkirchen gGmbH | |
Neunkirchen, Germany, 66538 | |
Beckenboden Zentrum München | |
München, Germany, 81679 | |
Medizinische Einrichtungen der RWTH | |
Aachen, Germany, 52074 | |
Praxis für Urologie | |
Bad Kreuznach, Germany, 55543 | |
Praxis für Urologie | |
Lahr, Germany, 77933 | |
Krankenhaus St. Trudpert | |
Pforzheim, Germany, 75177 | |
Praxis für Urologie | |
Günzburg, Germany, 89312 | |
Italy | |
Unità Spinale, Ospedale Niguarda | |
Milano, Italy, 20100 | |
Unità Spinale, Azienda Ospedaliera Careggi | |
Firenze, Italy, 50139 | |
Struttura Complessa di Neuro-Urologia | |
Torino, Italy, 1053 | |
Netherlands | |
General Urology Academisch Ziekenhuis Maastricht | |
Maastricht, Netherlands | |
UMC St. Radboud | |
Nijmegen, Netherlands, 6525 GA | |
Erasmus MC, Universitair Medisch Centrum Rotterdam | |
Rotterdam, Netherlands, 3000 CA | |
VU Medisch Centrum Amsterdam | |
Amsterdam, Netherlands, 1081 HV | |
Spain | |
Hospital San Rafael | |
Madrid, Spain, 28016 | |
Hospital Clínico Universitario Canarias | |
La Laguna, Spain, 38330 | |
Hospital Universitario La Fe | |
Valencia, Spain, 46009 | |
United Kingdom | |
Churchill Hospital | |
Oxford, United Kingdom, OX3 7LJ | |
St George's Hospital | |
London, United Kingdom, SW17 OQT | |
Southmead Hospital | |
Bristol, United Kingdom, BS10 5NB | |
Royal Berkshire Hospital | |
Reading, United Kingdom, RG1 5AN | |
Western General Hospital | |
Edinburgh, United Kingdom, EH4 2XU |
Study Director: | Benjamin Zakine, MD | Ipsen |
Responsible Party: | Ipsen ( Benjamin Zakine ) |
Study ID Numbers: | Y-79-52120-126 |
Study First Received: | December 18, 2007 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00578097 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: State Institute for Drug Control; Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines |
Signs and Symptoms Urinary Bladder, Overactive Botulinum Toxins Cystocele |
Urologic Diseases Urinary Bladder Diseases Peripheral Nervous System Agents Botulinum Toxin Type A |
Urinary Bladder, Overactive Anti-Dyskinesia Agents Urinary Bladder Diseases Physiological Effects of Drugs Neuromuscular Agents Pharmacologic Actions Urological Manifestations |
Signs and Symptoms Botulinum Toxins Urologic Diseases Therapeutic Uses Peripheral Nervous System Agents Botulinum Toxin Type A Central Nervous System Agents |