Conditions: Osteoarthritis Arthritis, Rheumatoid
Keywords: GI events in high risk GI arthritis patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4484
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Celecoxib intervention 2: Diclofenac + Omeprazole
Intervention descriptions: intervention 1: Participants are assigned to one of two groups in parallel for the duration of the study intervention 2: Participants are assigned to one of two groups in parallel for the duration of the study

Protocol document: