Back to resultsStudy About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Colonoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
Inclusion criteria:
- fistulizing CD
- CD < 6 months
- at least one insufficient fistula closure try
Exclusion criteria:
- CDAI > 200
- Abscesses
- CRP > 100
Sites / Locations
Outcomes
Primary Outcome Measures
Fistula closure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01012726
Brief Title
Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae
Official Title
FIST-MC-09 Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
not enough patients enrolled
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gerhard Rogler
4. Oversight
5. Study Description
Brief Summary
The investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Intervention Description
During the colonoscopy, we instill Acetylcystein and Doxycyline into the fistula.
Primary Outcome Measure Information:
Title
Fistula closure
Time Frame
01.08.2009 - 31.07.2012
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
fistulizing CD
CD < 6 months
at least one insufficient fistula closure try
Exclusion criteria:
CDAI > 200
Abscesses
CRP > 100
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae
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