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

This study has been completed.
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ClinicalTrials.gov Identifier:
First received: September 19, 2005
Last updated: September 12, 2007
Last verified: September 2007
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

Condition Intervention Phase
Anal Fissure
Drug: Botulinum toxin type A (Dysport)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.

Secondary Outcome Measures:
  • Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.

Estimated Enrollment: 152
Study Start Date: June 2003
Study Completion Date: December 2006

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00210444

Czech Republic
Faculty Nemocnice-III
Brno, Czech Republic, 639-01
Faculty Nemocnice
Hradec Kralove, Czech Republic, 500-05
Thomayer's Memorial Hospital
Prague, Czech Republic, 140-59
Consulting Room of Proctology
Gdansk, Poland, 80-371
Medical University of Lodz
Lodz, Poland, 90-447
Institute Clinique Fundeni
Bucharest, Romania, Sector 2
CHU Hopital Charles Nicolle de Tunis
Tunis, Tunisia, 1006
Sponsors and Collaborators
Study Director: Stefan Lempereur, MD Ipsen
  More Information

ClinicalTrials.gov Identifier: NCT00210444     History of Changes
Other Study ID Numbers: A-38-52120-714 
Study First Received: September 19, 2005
Last Updated: September 12, 2007
Health Authority: Poland: Ministry of Health
Czech Republic: State Institute for Drug Control
Romania: Ministry of Health
Tunisia: Office of Pharmacies and Medicines

Additional relevant MeSH terms:
Fissure in Ano
Anus Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 03, 2016