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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00210444 |
To evaluate the effect on healing rates of two different prognostic factors in patients treated with Dysport® for anal fissure: duration of fissure and dose of study drug
Condition | Intervention | Phase |
---|---|---|
Anal Fissure |
Drug: Botulinum toxin type A (Dysport) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicentre, Open, Randomised, Parallel Group, Dose Ranging Study to Define the Efficacy of Dysport® in the Treatment of Anal Fissure. |
Estimated Enrollment: | 152 |
Study Start Date: | June 2003 |
Study Completion Date: | December 2006 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
Faculty Nemocnice | |
Hradec Kralove, Czech Republic, 500-05 | |
Thomayer's Memorial Hospital | |
Prague, Czech Republic, 140-59 | |
Faculty Nemocnice-III | |
Brno, Czech Republic, 639-01 | |
Poland | |
Medical University of Lodz | |
Lodz, Poland, 90-447 | |
Consulting Room of Proctology | |
Gdansk, Poland, 80-371 | |
Romania | |
Institute Clinique Fundeni | |
Bucharest, Romania, Sector 2 | |
Tunisia | |
CHU Hopital Charles Nicolle de Tunis | |
Tunis, Tunisia, 1006 |
Study Director: | Stefan Lempereur, MD | Ipsen |
Study ID Numbers: | A-38-52120-714 |
Study First Received: | September 19, 2005 |
Last Updated: | September 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00210444 |
Health Authority: | Poland: Ministry of Health; Czech Republic: State Institute for Drug Control; Romania: Ministry of Health; Tunisia: Office of Pharmacies and Medicines |
Fissure in Ano Botulinum Toxins Digestive System Diseases Gastrointestinal Diseases |
Botulinum Toxin Type A Intestinal Diseases Rectal Diseases |
Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Neuromuscular Agents |
Peripheral Nervous System Agents Central Nervous System Agents Anus Diseases Pharmacologic Actions |