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

Viatris

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis; Arthritis, Rheumatoid

Treatments: Drug: Diclofenac + Omeprazole; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141102

A3191084

Details and patient eligibility

About

To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.

Enrollment: 4,484 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management
• Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit

Exclusion criteria

• Active GD ulceration or GD ulceration within 90 days of the screening visit.
• Concomitant use of low dose aspirin
• Previous MI, stroke or significant vascular disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4,484 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Celecoxib

B

Active Comparator group

Treatment:

Drug: Diclofenac + Omeprazole