Effect of Selective COX-2 Inhibition on Ulcer Healing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Arthritis, Gastric Ulcer

Intervention / Treatment
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* Drug: celecoxib
* Drug: Dologesics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastric ulcers confirmed by endoscopy Stop taking NSAIDs for 1 week prior to endoscopy Age 18 H. pylori negative Informed written consent Exclusion Criteria: Actively bleeding ulcers Ulcers showing dysplasia or malignancy Renal failure (serum creatinine >200umol/l) Previous gastric surgery Moribund or terminal malignancy Concomitant use of proton pump inhibitor, misoprostol, aspirin, steroid or anticoagulant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Celecoxib + Famotidine | Drug: celecoxib<br>* Celecoxib 200mg bd<br>|
| Active Comparator: 2<br>Dologesics + Famotidine | Drug: Dologesics<br>* Dologesics 2 tablets bd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ulcer healing |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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celecoxib, arthritis, ulcer healing