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

Ipsen

Status and phase

Completed

Phase 2

Conditions

Anal Fissure

Treatments

Biological: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00210444

A-38-52120-714

Details and patient eligibility

About

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

Enrollment

168 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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