Efficacy Study of Dysport® in the Treatment of Anal Fissure.
Phase 2
Completed
- Conditions
- Anal Fissure
- Registration Number
- NCT00210444
- Lead Sponsor
- Ipsen
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.
- Secondary Outcome Measures
Name Time Method Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.
Trial Locations
- Locations (7)
Faculty Nemocnice-III
🇨🇿Brno, Czechia
Consulting Room of Proctology
🇵🇱Gdansk, Poland
Thomayer's Memorial Hospital
🇨🇿Prague, Czechia
Faculty Nemocnice
🇨🇿Hradec Kralove, Czechia
Medical University of Lodz
🇵🇱Lodz, Poland
Institute Clinique Fundeni
🇷🇴Bucharest, Romania
CHU Hopital Charles Nicolle de Tunis
🇹🇳Tunis, Tunisia