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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2006-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Anal Fissure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Botulinum toxin type A

Intervention Type BIOLOGICAL

Other Intervention Names

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AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No