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

April 27, 2020 updated by: Ipsen

A Phase II, Multicentre, Open, Randomised, Parallel Group, Dose Ranging Study to Define the Efficacy of Dysport® in the Treatment of Anal Fissure.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 639-01
        • Faculty Nemocnice-III
      • Hradec Kralove, Czechia, 500-05
        • Faculty Nemocnice
      • Prague, Czechia, 140-59
        • Thomayer's Memorial Hospital
  • Poland
      • Gdansk, Poland, 80-371
        • Consulting Room of Proctology
      • Lodz, Poland, 90-447
        • Medical University of Lodz
  • Romania
      • Bucharest, Romania, Sector 2
        • Institute Clinique Fundeni
  • Tunisia
      • Tunis, Tunisia, 1006
        • CHU Hopital Charles Nicolle de Tunis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.

Secondary Outcome Measures

Outcome Measure
Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-38-52120-714

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anal Fissure

Clinical Trials on Botulinum toxin type A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe