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

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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Key information

Conditions

Anal Fissure Anus Diseases Digestive System Diseases Fissure in Ano Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty Nemocnice-III, Brno, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

Other names: AbobotulinumtoxinA (Dysport®)

Primary outcomes

Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.

Secondary outcomes

Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Phase II, Multicentre, Open, Randomised, Parallel Group, Dose Ranging Study to Define the Efficacy of Dysport® in the Treatment of Anal Fissure.

Important dates

Study start: 2003
Study completion: 2006
First posted: Sep 21, 2005
Registry last updated: Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed