Efficacy Study of Dysport® in the Treatment of Anal Fissure.
Information source: Ipsen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anal Fissure
Intervention: Botulinum toxin type A (Dysport) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Ipsen Official(s) and/or principal investigator(s):
Stefan Lempereur, MD, Study Director, Affiliation: Ipsen
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
Clinical Details
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 design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.
Secondary outcome: Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Faculty Nemocnice, Hradec Kralove 500-05, Czech Republic
Thomayer's Memorial Hospital, Prague 140-59, Czech Republic
Faculty Nemocnice-III, Brno 639-01, Czech Republic
Medical University of Lodz, Lodz 90-447, Poland
Consulting Room of Proctology, Gdansk 80-371, Poland
Institute Clinique Fundeni, Bucharest Sector 2, Romania
CHU Hopital Charles Nicolle de Tunis, Tunis 1006, Tunisia
Additional Information
Starting date: June 2003
Ending date: December 2006
Last updated: September 12, 2007
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