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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00153673 |
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 Drug: Dologesics |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
Official Title: | 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) |
Estimated Enrollment: | 200 |
Study Start Date: | February 2001 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Celecoxib + Famotidine
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Drug: celecoxib
Celecoxib 200mg bd
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2: Active Comparator
Dologesics + Famotidine
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Drug: Dologesics
Dologesics 2 tablets bd
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Francis K Chan, MD | 85226323143 | fklchan@cuhk.edu.hk |
Contact: Jessica Y Ching, MPH | 85226323524 | jessicaching@cuhk.edu.hk |
China | |
Endoscopy Center, Prince of Wales Hospital | Recruiting |
Hong Kong, China | |
Contact: Francis K Chan, MD 26323143 fklchan@cuhk.edu.hk | |
Contact: Jessica Y Ching, MPH 26323524 jessicaching@cuhk.edu.hk | |
Principal Investigator: Francis K Chan, MD | |
Sub-Investigator: Vincent W Wong, MD |
Principal Investigator: | Francis K Chan, MD | Chinese University of Hong Kong |
Responsible Party: | Chinese University of Hong Kong ( Francis K CHAN ) |
Study ID Numbers: | 5NA study |
Study First Received: | September 8, 2005 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00153673 History of Changes |
Health Authority: | Hong Kong: Department of Health |
celecoxib arthritis ulcer healing |
Anti-Inflammatory Agents Stomach Ulcer Celecoxib Gastrointestinal Diseases Ulcer Joint Diseases Cyclooxygenase Inhibitors Digestive System Diseases Stomach Diseases |
Musculoskeletal Diseases Famotidine Analgesics, Non-Narcotic Arthritis Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Peptic Ulcer |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Pathologic Processes Stomach Diseases Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peptic Ulcer |
Stomach Ulcer Celecoxib Joint Diseases Ulcer Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Digestive System Diseases Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |