Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae

This study has been terminated.
(not enough patients enrolled)
Sponsor:
Information provided by (Responsible Party):
Gerhard Rogler, University of Zurich
ClinicalTrials.gov Identifier:
NCT01012726
First received: November 11, 2009
Last updated: December 3, 2014
Last verified: December 2014
  Purpose

The investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients.


Condition Intervention
Crohn's Disease
Procedure: Colonoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FIST-MC-09 Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Fistula closure [ Time Frame: 01.08.2009 - 31.07.2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2009
Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Colonoscopy
    During the colonoscopy, we instill Acetylcystein and Doxycyline into the fistula.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • fistulizing CD
  • CD < 6 months
  • at least one insufficient fistula closure try

Exclusion criteria:

  • CDAI > 200
  • Abscesses
  • CRP > 100
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012726

Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
Gerhard Rogler
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Gerhard Rogler, Prof. Dr. Dr. Gerhard Rogler, University of Zurich
ClinicalTrials.gov Identifier: NCT01012726     History of Changes
Other Study ID Numbers: FIST-MC-09
Study First Received: November 11, 2009
Last Updated: December 3, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 27, 2015