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

Phase 4CompletedNCT00630929

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.388 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

388

Conditions

Osteoarthritis, Knee

Interventions

IbuprofenDRUG

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

PlaceboDRUG

Matched placebo orally for 6 weeks

CelecoxibDRUG

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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: 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

Locations (33)

Outcomes

Primary Outcomes

Change from baseline in patient's assessment of arthritis pain according to visual analogue scale

Time frame: Week 6

Secondary Outcomes

Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores

Time frame: Days 1-7

Change from baseline in patient's assessment of arthritis pain according to visual analogue scale

Time frame: Week 2

Change from baseline in patient and physician global assessments of arthritis

Time frame: Weeks 2 and 6

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index

Time frame: Week 6

The Pain Satisfaction Scale

Time frame: Week 6

The Patient Health Questionnaire (PHQ-9)

Time frame: Week 6

Measurement of upper gastrointestinal tolerability

Time frame: Weeks 2 and 6

Adverse events

Time frame: Weeks 2 and 6

Laboratory test results

Time frame: Week 6

Vital signs

Time frame: Weeks 2 and 6

Physical examination

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Bad Münder am Deister, Germany

Pfizer Investigational Site

Beckum, Germany

Pfizer Investigational Site

Berlin, Germany

Pfizer Investigational Site

Berlin, Germany

Pfizer Investigational Site

Berlin, Germany

Pfizer Investigational Site

Berlin, Germany

Pfizer Investigational Site

Ostseebad Damp, Germany

Pfizer Investigational Site

Schwerin, Germany

Pfizer Investigational Site

Stade, Germany

Pfizer Investigational Site

Tostedt, Germany

...and 23 more locations