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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014