Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED)

A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 50 mg t.i.d. in Patients With Osteoarthritis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092703

Enrollment

6000

Registered

2004-09-28

Start date

2002-06-27

Completion date

2003-11-01

Last updated

2024-08-15

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

Conditions

Osteoarthritis

Keywords

Arcoxia

Brief summary

The purpose of this study is to compare the gastrointestinal tolerability of an investigational drug to an approved drug in the treatment of osteoarthritis during one year treatment period.

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

* Osteoarthritis of the knee, hip, hand or spine which requires the use of medications for pain relief

Exclusion criteria

* Known allergies to the study drugs

Design outcomes

Primary

Measure	Time frame
Discontinuations due to clinical and laboratory gastrointestinal adverse experiences during a 1 year treatment period.	—

Outcome results

None listed

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