NCT01012726

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

November 11, 2009

Last Update Submit

December 3, 2014

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Fistula closure

    01.08.2009 - 31.07.2012

Interventions

ColonoscopyPROCEDURE

During the colonoscopy, we instill Acetylcystein and Doxycyline into the fistula.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • CDAI \> 200
  • Abscesses
  • CRP \> 100

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Dr. Gerhard Rogler

Study Record Dates

First Submitted

November 11, 2009

First Posted

November 13, 2009

Study Start

November 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2012

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

CH(1)