Effect of Selective COX-2 Inhibition on Ulcer Healing

This study has suspended participant recruitment.
(slow recruitment)
Sponsor:
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00153673
First received: September 8, 2005
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • ulcer healing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2001
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Celecoxib + Famotidine
Drug: celecoxib
Celecoxib 200mg bd
Active Comparator: 2
Dologesics + Famotidine
Drug: Dologesics
Dologesics 2 tablets bd

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 >200umol/l)
  • Previous gastric surgery
  • Moribund or terminal malignancy
  • Concomitant use of proton pump inhibitor, misoprostol, aspirin, steroid or anticoagulant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153673

Locations
China
Endoscopy Center, Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Francis K Chan, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Francis KL Chan, professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00153673     History of Changes
Other Study ID Numbers: 5NA study
Study First Received: September 8, 2005
Last Updated: February 18, 2014
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
celecoxib
arthritis
ulcer healing

Additional relevant MeSH terms:
Arthritis
Stomach Ulcer
Ulcer
Joint Diseases
Musculoskeletal Diseases
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Famotidine
Celecoxib
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014