Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)

A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 75 mg b.i.d. in Patients With Rheumatoid Arthritis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092742

Enrollment

4086

Registered

2004-09-28

Start date

2003-02-28

Completion date

2005-12-31

Last updated

2022-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Arcoxia

Brief summary

The purpose of this study is to evaluate the long-term safety of an investigational drug versus an approved drug for the relief of pain in patients with rheumatoid arthritis.

Detailed description

The duration of treatment is 12 months.

Interventions

DRUGMK0663, etoricoxib

DRUGComparator: Diclofenac sodium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Males and females 50 years or older with rheumatoid arthritis.

Exclusion criteria

* History of gastrointestinal malabsorption or inflammatory bowel disease * History of heart problems such as: congestive heart failure (CHF), heart attack or high blood pressure.

Design outcomes

Primary

Measure	Time frame
Discontinuations due to clinical and laboratory gastrointestinal adverse experiences	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026