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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Gastrointestinal Diseases
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Peptic Ulcer
Stomach Diseases
Celecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014