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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210444
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):

Brief 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

Condition or disease Intervention/treatment Phase
Anal Fissure Drug: Botulinum toxin type A (Dysport) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2003
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210444

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Faculty Nemocnice-III
Brno, Czechia, 639-01
Faculty Nemocnice
Hradec Kralove, Czechia, 500-05
Thomayer's Memorial Hospital
Prague, Czechia, 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
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen Identifier: NCT00210444     History of Changes
Other Study ID Numbers: A-38-52120-714
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents