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

October 21, 2011
February 12, 2013
December 2011
June 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01462747 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
An Open Prospective Study Evaluating the Efficacy and Safety of a Medical Device,KULIST, for the Treatment of Chronic, Non-complicated Perianal Fistulas

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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Perianal Fistulas
Device: KULIST
Twice daily dosing for 8 weeks
Experimental: KULIST
Medical Device, Activated carbon
Intervention: Device: KULIST
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
January 2013
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

    Exclusion Criteria

  6. Inflammatory Bowel Disease (IBD)
  7. Rectovaginal fistulas
  8. Rectourethral fistulas
  9. Rectovesical fistulas
  10. Extra-sphincteric and supra-sphincteric fistula according to Parks´classification
  11. Complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator.
  12. Any surgical treatment for perianal fistulas
  13. Colorectal and/or anal malignancy
  14. Other malignancy requiring active treatment
  15. Subcutaneous fistulas not involving any part of the external sphincter
  16. Other diseases which as per the investigator's opinion should be contraindicated
  17. Subjects who are not able to complete study procedures as per the investigator's opinion
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01462747
KULIST-001
No
Nordic Drugs AB
Nordic Drugs AB
Not Provided
Principal Investigator: Måns Bohe, MD, PhD Skane University Hospital
Nordic Drugs AB
February 2013

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