Skip to main content
OpenTrials
Completed

NCT Number: NCT00643799

Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis

To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis

Completed

Looking for future studies?

Notify Me

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, Montgomery, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
  • Functional Capacity Classification of I-III

Exclusion criteria

  • Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
  • Received acetaminophen within 24 hours of the baseline visit
  • Acute joint trauma at index joint within the past 3 months with active symptoms
  • History of gastrointestinal (GI) perforation, obstruction, or bleeding
  • Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
  • Received corticosteroids or hyaluronic acid within certain timeframe before study

Treatment and study plan

Celecoxib

Drug

200 mg oral capsule once daily for 6 months

Naproxen

Drug

500 mg oral capsule twice daily for 6 months

Placebo

Drug

Matched oral placebo for 6 months

Primary outcomes

  1. Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score

    Time frame: Month 6

Secondary outcomes

  1. Number of health care professional contacts

    Time frame: Throughout study

  2. Patient's and Physician's Satisfaction with Current Arthritis Therapy

    Time frame: Month 6

  3. Change in WOMAC Total Score from baseline

    Time frame: Month 6

  4. Change in WOMAC Subscales from baseline

    Time frame: Month 6

  5. Response in each WOMAC Subscale

    Time frame: Month 6

  6. Change in Medical Outcome Study sleep scale from baseline

    Time frame: Month 6

  7. Laboratory tests

    Time frame: Month 6

  8. Vital signs

    Time frame: Month 6

  9. Response in VAS

    Time frame: Month 6

  10. Change in Patient's and Physician's Global Assessment of Pain from baseline

    Time frame: Month 6

  11. Change in visual analog scale (VAS) from baseline

    Time frame: Month 6

  12. Adverse events

    Time frame: Throughout study

  13. Change in Gastrointestinal (GI) Distress Scale from Week 1

    Time frame: Month 6

  14. Change in GI Distress Scale from time of discontinuation of study drug

    Time frame: Month 6

  15. Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug)

    Time frame: Throughout study

  16. Number of hospitalizations, emergency room visits, and procedures

    Time frame: Throughout study

  17. Change in Work Limitation Questionnaire scale scores from baseline

    Time frame: Month 6

  18. Physical examination

    Time frame: Month 6

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-month Treatment of Subjects With Osteoarthritis of the Knee

Acronym: CLOAK

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Mar 26, 2008
Registry last updated
Feb 2, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.