Efficacy Study of Dysport® in the Treatment of Anal Fissure.
This study has been completed.
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00210444
First received: September 19, 2005
Last updated: September 12, 2007
Last verified: September 2007
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Botox
Drug Information available for:
OnabotulinumtoxinA
U.S. FDA Resources
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.
Secondary Outcome Measures:
- Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.
| Estimated Enrollment: | 152 |
| Study Start Date: | June 2003 |
| Study Completion Date: | December 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients having idiopathic anal fissure in the posterior anal midline
- Patients having anal fissure present for less than 6 months
- Patients having symptoms (pain) present for a minimum of 2 weeks and not responding after 2 weeks of standard therapy (diet, laxatives, sitz-bathes)
Exclusion Criteria:
- Patients having anal fistulas or anal fissure of various causes such as Crohn disease, Behcet infectious ulceration, anal suppuration, subfissural infiltration, abscesses, acute haemorrhoidal attacks or inflammatory bowel disease
- Patients having idiopathic anal fissure in the anterior anal midline
- Patients having lateral or multiple fissures
- Patients having anal or perianal cancer
- Patients who underwent previous anal surgery or have cicatricial alterations or post-surgical cicatricial lesions
- Patients receiving drugs affecting neuromuscular transmission
- Patients who have received topical anaesthetic within 3 days of injection
- Patients receiving local treatment by myorelaxing agent
- Patients receiving prohibited analgesics
- Patients having bleeding disturbances or currently using coumarin derivates
- Patients having myasthenia or any genetic muscle disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210444
Locations
| Czech Republic | |
| Faculty Nemocnice-III | |
| Brno, Czech Republic, 639-01 | |
| Faculty Nemocnice | |
| Hradec Kralove, Czech Republic, 500-05 | |
| Thomayer's Memorial Hospital | |
| Prague, Czech Republic, 140-59 | |
| Poland | |
| Consulting Room of Proctology | |
| Gdansk, Poland, 80-371 | |
| Medical University of Lodz | |
| Lodz, Poland, 90-447 | |
| Romania | |
| Institute Clinique Fundeni | |
| Bucharest, Romania, Sector 2 | |
| Tunisia | |
| CHU Hopital Charles Nicolle de Tunis | |
| Tunis, Tunisia, 1006 | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Stefan Lempereur, MD | Ipsen |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00210444 History of Changes |
| Other Study ID Numbers: | A-38-52120-714 |
| Study First Received: | September 19, 2005 |
| Last Updated: | September 12, 2007 |
| Health Authority: | Poland: Ministry of Health Czech Republic: State Institute for Drug Control Romania: Ministry of Health Tunisia: Office of Pharmacies and Medicines |
Additional relevant MeSH terms:
|
Fissure in Ano Anus Diseases Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Botulinum Toxins, Type A Botulinum Toxins |
Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013