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OpenTrials
Completed

NCT Number: NCT00620867

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

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, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ibuprofen

Drug

800 mg oral tablet three time daily with meals for 6 weeks

Celecoxib

Drug

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

Placebo

Other

matched placebo orally for 6 weeks

Primary outcomes

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

    Time frame: Week 6

Secondary outcomes

  1. Vital signs

    Time frame: Weeks 2 and 6

  2. Physical examination

    Time frame: Week 6

  3. Laboratory test results

    Time frame: Week 6

  4. Adverse events

    Time frame: Weeks 2 and 6

  5. Change from baseline in patient's and physician's global assessment of pain

    Time frame: Weeks 2 and 6

  6. Pain Satisfaction Scale

    Time frame: Days 1-7

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

    Time frame: Week 6

  8. Patient Health Questionnaire (PHQ-9)

    Time frame: Week 6

  9. Change from baseline in patient's assessment of arthritis pain according to VAS

    Time frame: Week 2

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
2002
Primary completion
2003
Study completion
2003
First posted
Feb 22, 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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