- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00153673
Effect of Selective COX-2 Inhibition on Ulcer Healing
April 20, 2017 updated by: Francis KL Chan, Chinese University of Hong Kong
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, China
- Endoscopy Center, Prince of Wales Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
Celecoxib + Famotidine
|
Celecoxib 200mg bd
|
ACTIVE_COMPARATOR: 2
Dologesics + Famotidine
|
Dologesics 2 tablets bd
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ulcer healing
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2001
Primary Completion (ACTUAL)
December 28, 2016
Study Completion (ACTUAL)
April 12, 2017
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (ESTIMATE)
September 12, 2005
Study Record Updates
Last Update Posted (ACTUAL)
April 21, 2017
Last Update Submitted That Met QC Criteria
April 20, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Stomach Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Intestinal Diseases
- Peptic Ulcer
- Duodenal Diseases
- Ulcer
- Arthritis
- Stomach Ulcer
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- 5NA study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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