Safety of Lumiracoxib in Patients With Osteoarthritis

A 6-Week Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Clinical Saftey Study to Evaluate Incidence of Predefined Gastrointestinal Adverse Events and Peripheral Edema in Subjects With Primary Osteoarthritis Treated With COX189 400 mg o-do Using Rofecoxib 25 mg o.d. as a Comparator

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00637949

Enrollment

309

Registered

2008-03-18

Start date

2000-12-31

Completion date

2001-03-31

Last updated

2008-03-18

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

Conditions

Osteoarthritis

Keywords

Osteoarthritis, lumiracoxib, rofecoxib, Cox-2, Osteoarthritis (primary osteoarthritis hip, hand, knee or spine (cervical or lumbar)

Brief summary

This safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator

Interventions

DEVICElumiracoxib

400 mg once daily, oral over 6 weeks

DRUGrofecoxib

25 mg, oral, daily over 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Age \>=50 years old * Primary osteoarthritis in hip, hand, knee or spine for at least 3 month * Pain in the target joint of moderate intensity * Written informed consent

Exclusion criteria

* Secondary osteoarthritis * Active upper gastro intestinal tract ulceration * Inflammatory joint disease * Gout * Clinically significant hepatic or renal disease Other in and

Design outcomes

Primary

Measure	Time frame
Incidence of at least one of seven predefined gastrointestinal adverse events	6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026