Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Nordic Drugs AB

ClinicalTrials.gov Identifier:

NCT01462747

First received: October 21, 2011

Last updated: February 12, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 21, 2011

Last Updated Date

February 12, 2013

Start Date ^ICMJE

December 2011

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical evaluation of fistula healing, change from baseline [ Time Frame: week 8 and 24 ] [ Designated as safety issue: No ]

Fistula assessed as healed/not healed

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01462747 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Anal ultrasonography, change from baseline [ Time Frame: week 8 and 24 ] [ Designated as safety issue: No ]
Healed/not healed
Patient assessment of Symptoms and Impact on Daily Function, change from baseline [ Time Frame: week 8 and 24 ] [ Designated as safety issue: No ]
By the use of VAS scales and questionnaires the patients subjective evaluations of symptoms and impact on daily living will be assessed
Safety, change from baseline [ Time Frame: week 2, 8, 24 ] [ Designated as safety issue: Yes ]
Standard collection of adverse events and adverse device effects.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas

Official Title ^ICMJE

An Open Prospective Study Evaluating the Efficacy and Safety of a Medical Device,KULIST, for the Treatment of Chronic, Non-complicated Perianal Fistulas

Brief Summary

The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas.

Detailed Description

Patients with chronic uncomplicated perianal fistulas located below levator ani will be treated twice daily with KULIST for 8 weeks. The efficacy will be evaluated by means of an overall clinical evaluation of fistula closure, as well as by anal ultrasonography.

Also changes in Patient Assessment of Symptoms and Impact on Daily Function will be evaluated. Safety will be evaluated by standard adverse event /adverse device effects reporting.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Perianal Fistulas

Intervention ^ICMJE

Device: KULIST

Twice daily dosing for 8 weeks

Study Arm (s)

Experimental: KULIST

Medical Device, Activated carbon

Intervention: Device: KULIST

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with perianal fistulas diagnosed by clinical examination and evaluated as "not healed/open"
Fistula classified as intersphincteric and transsphincteric according to Parks´classification (Parks 1976)
Superficial fistula involving a part of the external sphincter muscle
Age: ≥18 years and ≤ 75 years
Informed consent and/or Letter of Authority (as applicable) obtained

Exclusion Criteria
Inflammatory Bowel Disease (IBD)
Rectovaginal fistulas
Rectourethral fistulas
Rectovesical fistulas
Extra-sphincteric and supra-sphincteric fistula according to Parks´classification
Complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator.
Any surgical treatment for perianal fistulas
Colorectal and/or anal malignancy
Other malignancy requiring active treatment
Subcutaneous fistulas not involving any part of the external sphincter
Other diseases which as per the investigator's opinion should be contraindicated
Subjects who are not able to complete study procedures as per the investigator's opinion

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01462747

Other Study ID Numbers ^ICMJE

KULIST-001

Has Data Monitoring Committee

Responsible Party

Nordic Drugs AB

Study Sponsor ^ICMJE

Nordic Drugs AB

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Måns Bohe, MD, PhD

Skane University Hospital

Information Provided By

Nordic Drugs AB

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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