Effect of Selective COX-2 Inhibition on Ulcer Healing
Recruitment status was Recruiting
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| First Received Date ICMJE | September 8, 2005 | ||||||||
| Last Updated Date | March 25, 2010 | ||||||||
| Start Date ICMJE | February 2001 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
ulcer healing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
ulcer healing at week 8 | ||||||||
| Change History | Complete list of historical versions of study NCT00153673 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 | Effect of Selective COX-2 Inhibition on Ulcer Healing | ||||||||
| Official Title ICMJE | Phase III Study of a Double-Blind Randomized Comparison of Famotidine Plus Celecoxib Versus Dologesics for Gastric Ulcer Healing in Arthritis Patients (NSAID#5A Study) | ||||||||
| Brief Summary | The purpose of this study is to compare the effect of Famotidine plus a COX-2 inhibitor (celecoxib) with Famotidine plus dologesics in ulcer healing in arthritis patients. |
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| Detailed Description | For many years the integrity of the stomach mucosal barrier is thought to be maintained by mucosal prostaglandins (PG) synthesized by COX-1. However, the notion that COX-1 protects the stomach and COX-2 induces inflammation may be over-simplistic. In animal studies, COX-2, but not COX-1, is expressed in experimental gastric ulcer. Inhibition of COX-2 delays ulcer healing, indicating that PG derived from COX-2 contributes to restoring the mucosal barrier [1]. Whether this animal observation can be generalized to the human stomach is unknown. To date the biological functions of COX-1 and COX-2 in the healing of human gastric ulcer healing is unclear. Unlike experimental ulcers that only express COX-2, recently we have shown that both COX-1 and COX-2 are up-regulated in human gastric ulcers [2]. Furthermore, our preliminary results suggest that inhibition of COX-2 alone may not lead to a clinically significant delay in ulcer healing (refer to progress report). These observations suggest that peptic ulcer healing is more complex in the human stomach - both COX isoforms may be involved in the healing process. Inhibition of COX-2 alone may have less adverse effect than non-selective inhibition of both COX isoforms in ulcer healing. The current study aims to resolve the functional significance of COX-2 in human gastric ulcer from a biological and clinical perspective. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Intervention ICMJE |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2010 (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 |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00153673 | ||||||||
| Other Study ID Numbers ICMJE | 5NA study | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Francis K CHAN, Chinese University of Hong Kong | ||||||||
| Study Sponsor ICMJE | Chinese University of Hong Kong | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Chinese University of Hong Kong | ||||||||
| Verification Date | March 2010 | ||||||||
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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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