Status:
COMPLETED
Efficacy Study of Dysport® in the Treatment of Anal Fissure.
Lead Sponsor:
Ipsen
Conditions:
Anal Fissure
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00210444
Start Date
June 1 2003
End Date
December 1 2006
Last Update
April 29 2020
Active Locations (7)
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1
Faculty Nemocnice-III
Brno, Czechia, 639-01
2
Faculty Nemocnice
Hradec Králové, Czechia, 500-05
3
Thomayer's Memorial Hospital
Prague, Czechia, 140-59
4
Consulting Room of Proctology
Gdansk, Poland, 80-371