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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00210444
First received: September 19, 2005
Last updated: September 12, 2007
Last verified: September 2007
  Purpose

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
  Eligibility

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

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

Locations
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
Poland
Consulting Room of Proctology
Gdansk, Poland, 80-371
Medical University of Lodz
Lodz, Poland, 90-447
Romania
Institute Clinique Fundeni
Bucharest, Romania, Sector 2
Tunisia
CHU Hopital Charles Nicolle de Tunis
Tunis, Tunisia, 1006
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Stefan Lempereur, MD Ipsen
  More Information

No publications provided

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
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014