Effect of Selective COX-2 Inhibition on Ulcer Healing
Primary Purpose
Arthritis, Gastric Ulcer
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
celecoxib
Dologesics
Sponsored by

About this trial
This is an interventional treatment trial for Arthritis focused on measuring celecoxib, arthritis, ulcer healing
Eligibility 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
Sites / Locations
- Endoscopy Center, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Celecoxib + Famotidine
Dologesics + Famotidine
Outcomes
Primary Outcome Measures
ulcer healing
Secondary Outcome Measures
Full Information
NCT ID
NCT00153673
First Posted
September 8, 2005
Last Updated
April 20, 2017
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00153673
Brief Title
Effect of Selective COX-2 Inhibition on Ulcer Healing
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
December 28, 2016 (Actual)
Study Completion Date
April 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Gastric Ulcer
Keywords
celecoxib, arthritis, ulcer healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Celecoxib + Famotidine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Dologesics + Famotidine
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Description
Celecoxib 200mg bd
Intervention Type
Drug
Intervention Name(s)
Dologesics
Intervention Description
Dologesics 2 tablets bd
Primary Outcome Measure Information:
Title
ulcer healing
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis K Chan, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Center, Prince of Wales Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Selective COX-2 Inhibition on Ulcer Healing
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