Post-operative Crohn's Endoscopic Recurrence Study (POCER)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Melbourne
Information provided by (Responsible Party):
Michael Kamm, University of Melbourne
ClinicalTrials.gov Identifier:
NCT00989560
First received: October 2, 2009
Last updated: March 12, 2012
Last verified: March 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 2, 2009 | ||||||||
| Last Updated Date | March 12, 2012 | ||||||||
| Start Date ICMJE | August 2009 | ||||||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Endoscopic recurrence of disease [ Time Frame: 18 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00989560 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 | Post-operative Crohn's Endoscopic Recurrence Study | ||||||||
| Official Title ICMJE | Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause | ||||||||
| Brief Summary | This randomised, controlled study aims to evaluate the impact of endoscopic assessment, and adjustment of therapy, after surgery in patients with Crohn's disease. The primary endpoint is the severity of endoscopic recurrence. In addition, tissue will be collected for microbiological and immunological analysis. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Crohn's Disease | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 175 | ||||||||
| Estimated Completion Date | February 2013 | ||||||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Australia | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00989560 | ||||||||
| Other Study ID Numbers ICMJE | HREC-A 077/09 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Michael Kamm, University of Melbourne | ||||||||
| Study Sponsor ICMJE | University of Melbourne | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Melbourne | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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