Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)

Organon

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Comparator: placebo; Drug: Comparator: diclofenac; Drug: etoricoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00264147

2005_077

0663-086

Details and patient eligibility

About

To assess the clinically active dose range of study medication in the treatment of patients with rheumatoid arthritis.

Enrollment: 761 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with diagnosed rheumatoid arthritis (RA) for at least 6 months prior who is otherwise judged to be in general good health and who is currently taking nonsteroidal anti-inflammatory drugs (NSAIDS) to treat his/her RA symptoms
• Patient will need to stop taking these medications in order to participate, but can continue taking his/her other anti-rheumatic medications as long as they have been stable for certain periods of time

Exclusion criteria

• Patients with a disease or medical condition(s) that could worsen or interfere with the evaluation of the effectiveness of study medication are not allowed to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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761 participants in 7 patient groups, including a placebo group

Period I: 1

Experimental group

Description:

etoricoxib

Treatment:

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Period I: 2

Experimental group

Description:

etoricoxib

Treatment:

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Period I: 3

Experimental group

Description:

etoricoxib

Treatment:

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Period I: 4

Experimental group

Description:

etoricoxib

Treatment:

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Period I: 5

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: placebo

Period II: 1

Experimental group

Description:

etoricoxib

Treatment:

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Drug: etoricoxib

Period II: 2

Active Comparator group

Description:

diclofenac

Treatment:

Drug: Comparator: diclofenac