Efficacy Study of Dysport® in the Treatment of Anal Fissure. | NCT00210444

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

NCT00210444

Sponsor

Ipsen

Status

Completed

Last Update Posted

Apr 29, 2020Actual

Enrollment

168Actual

Phase

Phase 2

Conditions

Anal Fissure

Interventions

Botulinum toxin type A

Countries

Czechia
Poland
Romania
Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Sep 19, 2005

First Submission Date that Met QC Criteria

Sep 19, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2020

Last Update Posted Date

Apr 29, 2020Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

168Actual

Name	Type	Description	Arm Group Labels	Other Names
Botulinum toxin type A	Biological			AbobotulinumtoxinA (Dysport®)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.

Secondary Outcomes

Measure	Description	Time Frame
Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ipsen Medical Director	Ipsen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Faculty Nemocnice-III		Brno		639-01	Czechia
Faculty Nemocnice

ID	Term
D005401	Fissure in Ano

ID	Term
D001004	Anus Diseases
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A
C542869	abobotulinumtoxinA

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided