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Safety of Lumiracoxib in Patients With Osteoarthritis

NCT ID: NCT00637949

Last Updated: 2008-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

309 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2001-03-31

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

lumiracoxib

Intervention Type DEVICE

400 mg once daily, oral over 6 weeks

2

Group Type ACTIVE_COMPARATOR

rofecoxib

Intervention Type DRUG

25 mg, oral, daily over 6 weeks

Interventions

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lumiracoxib

400 mg once daily, oral over 6 weeks

Intervention Type DEVICE

rofecoxib

25 mg, oral, daily over 6 weeks

Intervention Type DRUG

Other Intervention Names

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Prexige Vioxx

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

References

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Stricker K, Yu S, Krammer G. A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients. BMC Musculoskelet Disord. 2008 Sep 8;9:118. doi: 10.1186/1471-2474-9-118.

Reference Type DERIVED
PMID: 18778469 (View on PubMed)

Other Identifiers

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CCOX189A2307

Identifier Type: -

Identifier Source: org_study_id