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.

Condition	Intervention	Phase
Arthritis Gastric ulcer	Drug: celecoxib	Phase III

Further Study Details: 

Primary Outcomes: ulcer healing at week 8
Expected Total Enrollment:  200

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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 >200mol/l)
• Previous gastric surgery
• Moribund or terminal malignancy
• Concomitant use of proton pump inhibitor, misoprostol, aspirin, steroid or anticoagulant

Please refer to this study by ClinicalTrials.gov identifier  NCT00153673

Francis K Chan, MD      85226323143    fklchan@cuhk.edu.hk
Jessica Y Ching, MPH      85226323524    jessicaching@cuhk.edu.hk

China
      Endoscopy Center, Prince of Wales Hospital, Hong Kong,  China; Recruiting

Study chairs or principal investigators

Francis K Chan, MD,  Principal Investigator,  Chinese University of Hong Kong   

Study ID Numbers:  5NA study
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00153673
Health Authority: Hong Kong: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13