Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)

NCT ID: NCT00630929

Last Updated: 2021-02-21

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

PHASE4

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-02-29

Brief Summary

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To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

Detailed Description

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Conditions

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Osteoarthritis, Knee

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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A

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

800 mg oral tablet 3 times daily with meals for 6 weeks

C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo orally for 6 weeks

B

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

200 mg oral capsule once daily with morning meal for 6 weeks

Interventions

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Ibuprofen

800 mg oral tablet 3 times daily with meals for 6 weeks

Intervention Type DRUG

Placebo

Matched placebo orally for 6 weeks

Intervention Type DRUG

Celecoxib

200 mg oral capsule once daily with morning meal for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged \>=40 years old
* Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
* Functional capacity class of I-III

Exclusion Criteria

* Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
* Acute joint trauma at index joint within the past 3 months with active symptoms
* Score of \>=20 on PHQ-9 or score of \>=1 on PHQ-9 item i
* Use of mobility assisting device for \<6 weeks or use of walker
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bad Münder am Deister, , Germany

Site Status

Pfizer Investigational Site

Beckum, , Germany

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Pfizer Investigational Site

Berlin, , Germany

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Pfizer Investigational Site

Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Ostseebad Damp, , Germany

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Schwerin, , Germany

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Stade, , Germany

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Tostedt, , Germany

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Weener, , Germany

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Barcelona, , Spain

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Barcelona, , Spain

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Cadiz, , Spain

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Guadalajara, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Oviedo, , Spain

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Seville, , Spain

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Valencia, , Spain

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Chelmsly WOOD, Birmingham, United Kingdom

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Truro, Cornwall, United Kingdom

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Chorley, Lancs, United Kingdom

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Liverpool, Lancs, United Kingdom

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Cannock, Mid Staffordshire, United Kingdom

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Addlestone, Surrey, United Kingdom

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Huddersfield, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Pfizer Investigational Site

Wigan, , United Kingdom

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Countries

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Germany Spain United Kingdom

References

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Gordo AC, Walker C, Armada B, Zhou D. Efficacy of celecoxib versus ibuprofen for the treatment of patients with osteoarthritis of the knee: A randomized double-blind, non-inferiority trial. J Int Med Res. 2017 Feb;45(1):59-74. doi: 10.1177/0300060516673707. Epub 2017 Jan 12.

Reference Type DERIVED
PMID: 28222627 (View on PubMed)

Related Links

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Other Identifiers

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A3191062

Identifier Type: -

Identifier Source: org_study_id

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