Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis CONDOR

Not Applicable

• Registration Number: PER-077-05
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-06
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Outpatient or hospitalized patient.
2. Subjects with a clinical diagnosis of OA or RA.
3. Subjects expected to require regular anti-inflammatory therapy for the management of arthritis symptoms.
4. Subjects must be> 60 years old with or without a history of GD ulcer; or be of any age> 18 years and have a GD ulcer documented 90 days or more before the screening visit.
5. H pylori tests done in the selection process are negative.
6. Women of childbearing age should not be pregnant or nursing.
7. Women of childbearing age should be using an effective contraceptive method.
8. Obtain informed consent in writing.

Exclusion Criteria

1. Hemorrhage of GI ulcer or GD ulcer active 90 days or less before the screening visit.
2. Current use of anticoagulants, lithium, anti-rheumatic drugs to modify disease (DMARDs), corticosteroids, NSAIDs, proton pump inhibitors, sucralfate, misoprostol or regular use of an antagonist of the H2 receptor of histamine.
3. Subjects using aspirin.
4. Subjects using other antiplatelet agents.
5. Subjects with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous procedure of revascularization to the coronary, carotid, cerebral, renal, aortic or peripheral arteries.
6. History of gastric or duodenal surgery other than repair of the patch / seam.
7. Presence of erosive esophagitis, obstruction of the gastric outlet
8. Malignancy or history of malignancy.
9. Pregnant or lactating women, or women of potential age to conceive that they are not using an acceptable method of contraception.
10. Participation in any other study that involves research or commercialized products, concomitantly or within 30 days prior to entering the study.
11. Current abuse or history of alcohol abuse and / or any other substance.
12. Previous participation in this study.
13. History of intolerance or hypersensitivity to diclofenac, celecoxib, omeprazole, NSAIDs, aspirin and sulfonamides.
14. Possibility of requiring treatment during the study period with medications not allowed by the study protocol.
15. Damaged liver function or damaged kidney function.
16. Any other Basal condition or finding that may increase
the risk to the subject or decrease the possibility of obtaining satisfactory data to achieve the objectives of the study.
17. Anemia with Hb <11.5g / dI.
18. Suspected or clinical diagnosis of inflammatory bowel disease.
19. Congestive heart failure.
20. Subjects that are considered to have some requirement for the continued use of a PPI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation of the following events: a) Gastroduodenal hemorrhage b) Gastric outlet obstruction c) Gastroduodenal, small bowel or large intestine perforation d) Small bowel hemorrhage e) Large bowel hemorrhage f) Clinically important anemia with an origin GI defined g) Acute GI hemorrhage of unknown origin, including suspected small bowel hemorrhage h) Clinically important anemia with suspected occult GI origin including possible loss of small bowel blood.<br><br>Measure:Incidence of clinically important upper / lower GI events (CSULGIESs).<br>Timepoints:Physical exam: Monthly.<br>EGD, Colonoscopy, Fecal occult blood (FOB): When necessary.<br>