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

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ClinicalTrials.gov Identifier: NCT01012726
Recruitment Status : Terminated (not enough patients enrolled)
First Posted : November 13, 2009
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Gerhard Rogler, University of Zurich

Tracking Information
First Submitted Date  ICMJE November 11, 2009
First Posted Date  ICMJE November 13, 2009
Last Update Posted Date December 4, 2014
Study Start Date  ICMJE November 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2009)
Fistula closure [ Time Frame: 01.08.2009 - 31.07.2012 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01012726 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae
Official Title  ICMJE FIST-MC-09 Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae
Brief Summary The investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE Procedure: Colonoscopy
During the colonoscopy, we instill Acetylcystein and Doxycyline into the fistula.
Study Arms Not Provided
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 Terminated
Estimated Enrollment  ICMJE
 (submitted: November 12, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date July 2012
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

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

Exclusion criteria:

  • CDAI > 200
  • Abscesses
  • CRP > 100
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01012726
Other Study ID Numbers  ICMJE FIST-MC-09
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gerhard Rogler, University of Zurich
Study Sponsor  ICMJE Gerhard Rogler
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
PRS Account University of Zurich
Verification Date December 2014

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