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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00643799
Collaborator
(none)
586
Enrollment
51
Locations
3
Arms
10.1
Duration (Months)
11.5
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
586 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Jan 1, 2005
Actual Study Completion Date :
Jan 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: Celecoxib
200 mg oral capsule once daily for 6 months
Active Comparator: B

Drug: Naproxen
500 mg oral capsule twice daily for 6 months
Placebo Comparator: C

Drug: Placebo
Matched oral placebo for 6 months

Outcome Measures

Primary Outcome Measures

  1. Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score [Month 6]

Secondary Outcome Measures

  1. Number of health care professional contacts [Throughout study]

  2. Patient's and Physician's Satisfaction with Current Arthritis Therapy [Month 6]

  3. Change in WOMAC Total Score from baseline [Month 6]

  4. Change in WOMAC Subscales from baseline [Month 6]

  5. Response in each WOMAC Subscale [Month 6]

  6. Change in Medical Outcome Study sleep scale from baseline [Month 6]

  7. Laboratory tests [Month 6]

  8. Vital signs [Month 6]

  9. Response in VAS [Month 6]

  10. Change in Patient's and Physician's Global Assessment of Pain from baseline [Month 6]

  11. Change in visual analog scale (VAS) from baseline [Month 6]

  12. Adverse events [Throughout study]

  13. Change in Gastrointestinal (GI) Distress Scale from Week 1 [Month 6]

  14. Change in GI Distress Scale from time of discontinuation of study drug [Month 6]

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

  16. Number of hospitalizations, emergency room visits, and procedures [Throughout study]

  17. Change in Work Limitation Questionnaire scale scores from baseline [Month 6]

  18. Physical examination [Month 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Montgomery Alabama United States 36106
2 Pfizer Investigational Site Phoenix Arizona United States 85014
3 Pfizer Investigational Site Tempe Arizona United States 85282
4 Pfizer Investigational Site Buena Park California United States 90620
5 Pfizer Investigational Site Paramount California United States 90723
6 Pfizer Investigational Site Rancho Mirage California United States 92270
7 Pfizer Investigational Site San Diego California United States 92103
8 Pfizer Investigational Site San Diego California United States 92108
9 Pfizer Investigational Site Denver Colorado United States 80230
10 Pfizer Investigational Site Washington District of Columbia United States 20006
11 Pfizer Investigational Site Clearwater Florida United States 33761
12 Pfizer Investigational Site DeLand Florida United States 32720
13 Pfizer Investigational Site Jacksonville Florida United States 32204
14 Pfizer Investigational Site Miami Florida United States 33186
15 Pfizer Investigational Site Ocala Florida United States 34474
16 Pfizer Investigational Site Orlando Florida United States 32804
17 Pfizer Investigational Site Pembroke Pines Florida United States 33024
18 Pfizer Investigational Site Tampa Florida United States 33614
19 Pfizer Investigational Site Zephyrhills Florida United States 33542
20 Pfizer Investigational Site Rockford Illinois United States 61103
21 Pfizer Investigational Site Wichita Kansas United States 67207
22 Pfizer Investigational Site Wichita Kansas United States 67212
23 Pfizer Investigational Site Lexington Kentucky United States 40503
24 Pfizer Investigational Site Lexington Kentucky United States 40515
25 Pfizer Investigational Site Covington Louisiana United States 70433
26 Pfizer Investigational Site Metairie Louisiana United States 70006
27 Pfizer Investigational Site Clinton Maryland United States 20735
28 Pfizer Investigational Site Greenbelt Maryland United States 20770
29 Pfizer Investigational Site Hagerstown Maryland United States 21740
30 Pfizer Investigational Site Wheaton Maryland United States 20902
31 Pfizer Investigational Site Milford Massachusetts United States 01757
32 Pfizer Investigational Site Lansing Michigan United States 48910
33 Pfizer Investigational Site Flowood Mississippi United States 39232
34 Pfizer Investigational Site Kansas City Missouri United States 64114
35 Pfizer Investigational Site Lincoln Nebraska United States 68506
36 Pfizer Investigational Site Lincoln Nebraska United States 68516
37 Pfizer Investigational Site New York New York United States 10022
38 Pfizer Investigational Site Beachwood Ohio United States 44122
39 Pfizer Investigational Site Columbus Ohio United States 43124
40 Pfizer Investigational Site Columbus Ohio United States 43215
41 Pfizer Investigational Site Columbus Ohio United States 43222
42 Pfizer Investigational Site Oklahoma City Oklahoma United States 73103
43 Pfizer Investigational Site Bethlehem Pennsylvania United States 18015
44 Pfizer Investigational Site Duncansville Pennsylvania United States 16635
45 Pfizer Investigational Site Media Pennsylvania United States 19603
46 Pfizer Investigational Site Warwick Rhode Island United States 02886
47 Pfizer Investigational Site Austin Texas United States 78705
48 Pfizer Investigational Site Dallas Texas United States 75235
49 Pfizer Investigational Site San Angelo Texas United States 76904
50 Pfizer Investigational Site Salt Lake City Utah United States 84109
51 Pfizer Investigational Site Salt Lake City Utah United States 84121

Sponsors and Collaborators

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

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00643799
Other Study ID Numbers:
  • A3191152
First Posted:
Mar 26, 2008
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Celecoxib
Naproxen

Study Results

No Results Posted as of Feb 2, 2021