Efficacy Study of Dysport® in the Treatment of Anal Fissure.

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 152
• Participant gender: Both

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA
• Last Updated: 2007-09-12

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