Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen (PRECISION)

Viatris

Status and phase: Completed; Phase 4

Conditions: Arthritis, Rheumatoid

Treatments: Drug: celecoxib; Drug: Naproxen; Drug: Ibuprofen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00346216

2004-002441-13 (EudraCT Number)

PRECISION TRIAL (Other Identifier)

A3191172

Details and patient eligibility

About

To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.

Enrollment: 24,081 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.

Exclusion criteria

• Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
• Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial
• Subjects require treatment with aspirin > 325 mg /day
• Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24,081 participants in 3 patient groups

celecoxib

Experimental group

Description:

subject receives celecoxib and dummy (placebo) ibuprofen and naproxen

Treatment:

Drug: celecoxib

ibuprofen

Active Comparator group

Description:

subject receives ibuprofen and dummy (placebo) celecoxib and naproxen

Treatment:

Drug: Ibuprofen

naproxen

Active Comparator group

Description:

subject receives naproxen and dummy (placebo) celecoxib and ibuprofen

Treatment:

Drug: Naproxen