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NCT00210444 Clinical Trial

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

Anal Fissure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00210444
Other study ID # A-38-52120-714
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2003
Est. completion date December 2006

Study information
Verified date April 2020
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 168
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Botulinum toxin type A

Locations
Country Name City State
Czechia Faculty Nemocnice-III Brno
Czechia Faculty Nemocnice Hradec Kralove
Czechia Thomayer's Memorial Hospital Prague
Poland Consulting Room of Proctology Gdansk
Poland Medical University of Lodz Lodz
Romania Institute Clinique Fundeni Bucharest
Tunisia CHU Hopital Charles Nicolle de Tunis Tunis

Sponsors (1)
Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

Czechia,  Poland,  Romania,  Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.
Secondary Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.
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