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Completed

NCT Number: NCT00630929

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

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Bad Münder am Deister, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

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

Placebo

Drug

Matched placebo orally for 6 weeks

Celecoxib

Drug

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

Primary outcomes

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

    Time frame: Week 6

Secondary outcomes

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

    Time frame: Days 1-7

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

    Time frame: Week 2

  3. Change from baseline in patient and physician global assessments of arthritis

    Time frame: Weeks 2 and 6

  4. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: Week 6

  5. The Pain Satisfaction Scale

    Time frame: Week 6

  6. The Patient Health Questionnaire (PHQ-9)

    Time frame: Week 6

  7. Measurement of upper gastrointestinal tolerability

    Time frame: Weeks 2 and 6

  8. Adverse events

    Time frame: Weeks 2 and 6

  9. Laboratory test results

    Time frame: Week 6

  10. Vital signs

    Time frame: Weeks 2 and 6

  11. Physical examination

    Time frame: Week 6

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee

Important dates

Study start
2003
Study completion
2004
First posted
Mar 7, 2008
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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