Efficacy Study of Dysport® in the Treatment of Anal Fissure.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00210444|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 14, 2007
|Condition or disease||Intervention/treatment||Phase|
|Anal Fissure||Drug: Botulinum toxin type A (Dysport)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||June 2003|
|Actual Study Completion Date :||December 2006|
- Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.
- Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210444
|Brno, Czech Republic, 639-01|
|Hradec Kralove, Czech Republic, 500-05|
|Thomayer's Memorial Hospital|
|Prague, Czech Republic, 140-59|
|Consulting Room of Proctology|
|Gdansk, Poland, 80-371|
|Medical University of Lodz|
|Lodz, Poland, 90-447|
|Institute Clinique Fundeni|
|Bucharest, Romania, Sector 2|
|CHU Hopital Charles Nicolle de Tunis|
|Tunis, Tunisia, 1006|
|Study Director:||Stefan Lempereur, MD||Ipsen|