Efficacy Study of Dysport® in the Treatment of Anal Fissure. - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00210444

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 II

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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.

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
Hradec Kralove, Czech Republic, 500-05
Thomayer's Memorial Hospital
Prague, Czech Republic, 140-59
Faculty Nemocnice-III
Brno, Czech Republic, 639-01
Poland
Medical University of Lodz
Lodz, Poland, 90-447
Consulting Room of Proctology
Gdansk, Poland, 80-371
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

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

Study placed in the following topic categories:

Fissure in Ano
Botulinum Toxins
Digestive System Diseases
Gastrointestinal Diseases

Botulinum Toxin Type A
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents

Peripheral Nervous System Agents
Central Nervous System Agents
Anus Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009