Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

Conditions

• Arthritis, Rheumatoid

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• celecoxib — DRUG
  100 to 200 mg twice daily, taken by mouth
• Ibuprofen — DRUG
  ibuprofen 600 mg to 800 mg three times daily, taken by mouth
• Naproxen — DRUG
  naproxen 375mg to 500 mg twice daily, taken by mouth

Study Details

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.

Key Dates

First listed

Jun 29, 2006

Start date

Oct 4, 2006

Status verified

Mar 2021

Primary completion

Apr 12, 2016

Completion

Apr 12, 2016

Study Design

Enrollment

24,081 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: celecoxib
  subject receives celecoxib and dummy (placebo) ibuprofen and naproxen
• Active Comparator: ibuprofen
  subject receives ibuprofen and dummy (placebo) celecoxib and naproxen
• Active Comparator: naproxen
  subject receives naproxen and dummy (placebo) celecoxib and ibuprofen

Primary Outcome Measure

The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). [ Time Frame: Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months ]

Locations (871)

Find similar trials in Alabaster, AL

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