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

Primary Purpose

Anal Fissure

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
Ipsen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fissure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty Nemocnice-III
  • Faculty Nemocnice
  • Thomayer's Memorial Hospital
  • Consulting Room of Proctology
  • Medical University of Lodz
  • Institute Clinique Fundeni
  • CHU Hopital Charles Nicolle de Tunis

Outcomes

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.

Full Information

First Posted
September 19, 2005
Last Updated
April 27, 2020
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00210444
Brief Title
Efficacy Study of Dysport® in the Treatment of Anal Fissure.
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 Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fissure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Primary Outcome Measure Information:
Title
Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.
Secondary Outcome Measure Information:
Title
Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Faculty Nemocnice-III
City
Brno
ZIP/Postal Code
639-01
Country
Czechia
Facility Name
Faculty Nemocnice
City
Hradec Kralove
ZIP/Postal Code
500-05
Country
Czechia
Facility Name
Thomayer's Memorial Hospital
City
Prague
ZIP/Postal Code
140-59
Country
Czechia
Facility Name
Consulting Room of Proctology
City
Gdansk
ZIP/Postal Code
80-371
Country
Poland
Facility Name
Medical University of Lodz
City
Lodz
ZIP/Postal Code
90-447
Country
Poland
Facility Name
Institute Clinique Fundeni
City
Bucharest
ZIP/Postal Code
Sector 2
Country
Romania
Facility Name
CHU Hopital Charles Nicolle de Tunis
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia

12. IPD Sharing Statement

Learn more about this trial

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

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