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A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00418782
Collaborator
(none)
212
Enrollment
46
Locations
3
Arms
7
Duration (Months)
4.6
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CE-224535 is a new medication being developed as an analgesic and anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate the analgesic and anti inflammatory efficacy and safety of CE 224,535 versus placebo and naproxen treatment in patients with OA knee pain.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
212 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicenter Study Of CE-224,535 In Subjects With Osteoarthritic Pain Of The Knee
Study Start Date :
Jan 1, 2007
Actual Study Completion Date :
Aug 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Drug: naproxen
Experimental: 2

Drug: CE-224535
Placebo Comparator: 3

Drug: placebo

Outcome Measures

Primary Outcome Measures

  1. To determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral multiple doses of CE 224,535 in subjects with OA of the knee [ongoing]

  2. The primary endpoint is the change from Baseline (Day 1) to Week 2 (Day 14) in the WOMAC Pain domain score. [Day 1-14]

Secondary Outcome Measures

  1. The change from Baseline to each day (Days 1 to 6) and over the average response in Days 1 to 6 using an 11 point numeric rating scale (NRS) from 0-10 on daily pain diary; [(Days 1 to 6)]

  2. Patient's Global Impression of Change (PGIC) at Week 2; [Week 2]

  3. The change from Baseline to Weeks 1 and 2 in the Patient's Global Assessment of Arthritic Condition; [Baseline to Weeks 1 and 2]

  4. The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score; [Day 7]

  5. The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Stiffness domain score; [Days 7 and 14]

  6. The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Physical Function domain score; [Days 7 and 14]

  7. The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Total Score by simple summation; [Days 7 and 14]

  8. The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Importance Weighted Total Score; [Days 7 and 14]

  9. The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS) [Weeks 1 and 2]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Is a healthy adult 18 to 75 years of age, inclusive, in general good health and with diagnosis of knee OA, as determined by the American College of Rheumatology (ACR) clinical/radiographic classification criteria for OA of the knee.

  • Women must be of non childbearing potential (amenorrhea for at least 1 year PLUS have a serum follicle stimulating hormone (FSH) level >30 IU/L, bilateral oophorectomy or hysterectomy), and have a confirmed negative serum pregnancy test at the screening visit prior to randomization.

Exclusion Criteria:

  • History of other diseases that may involve the study joint, including inflammatory joint diseases, crystalline disease, endocrinopathies, metabolic diseases, infections, neuropathic disorders, avascular necrosis, Paget's disease, or tumors.

  • Women of childbearing potential, or who are pregnant or lactating.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Anniston Alabama United States 36207
2 Pfizer Investigational Site Bayou La Batre Alabama United States 36509
3 Pfizer Investigational Site Birmingham Alabama United States 35209
4 Pfizer Investigational Site Birmingham Alabama United States 35216
5 Pfizer Investigational Site Birmingham Alabama United States 35242
6 Pfizer Investigational Site Hot Springs Arkansas United States 71913
7 Pfizer Investigational Site Northridge California United States 91325
8 Pfizer Investigational Site Sacramento California United States 95825
9 Pfizer Investigational Site Tarzana California United States 91356
10 Pfizer Investigational Site Denver Colorado United States 80204
11 Pfizer Investigational Site Denver Colorado United States 80206
12 Pfizer Investigational Site Westminster Colorado United States 80030
13 Pfizer Investigational Site Clearwater Florida United States 33761
14 Pfizer Investigational Site DeFuniak Springs Florida United States 32435
15 Pfizer Investigational Site Destin Florida United States 32541
16 Pfizer Investigational Site Pensacola Florida United States 32503
17 Pfizer Investigational Site Chicago Illinois United States 60053
18 Pfizer Investigational Site Gurnee Illinois United States 60031
19 Pfizer Investigational Site Avon Indiana United States 46123
20 Pfizer Investigational Site Indianapolis Indiana United States 46250
21 Pfizer Investigational Site Gretna Louisiana United States 70056
22 Pfizer Investigational Site Kenner Louisiana United States 70065
23 Pfizer Investigational Site Metairie Louisiana United States 70002
24 Pfizer Investigational Site Baltimore Maryland United States 21218
25 Pfizer Investigational Site Frederick Maryland United States 21702
26 Pfizer Investigational Site Flowood Mississippi United States 39232
27 Pfizer Investigational Site Columbia Missouri United States 65212
28 Pfizer Investigational Site Kansas City Missouri United States 64114
29 Pfizer Investigational Site Missoula Montana United States 59802
30 Pfizer Investigational Site Trenton New Jersey United States 08611
31 Pfizer Investigational Site Beavercreek Ohio United States 45440
32 Pfizer Investigational Site Cincinnati Ohio United States 45242
33 Pfizer Investigational Site Kettering Ohio United States 45429
34 Pfizer Investigational Site Ashland Oregon United States 97520
35 Pfizer Investigational Site Eugene Oregon United States 97404
36 Pfizer Investigational Site Duncansville Pennsylvania United States 16635
37 Pfizer Investigational Site Summerville South Carolina United States 29485
38 Pfizer Investigational Site Collierville Tennessee United States 38017
39 Pfizer Investigational Site Knoxville Tennessee United States 37909-1900
40 Pfizer Investigational Site Memphis Tennessee United States 38104
41 Pfizer Investigational Site Bryan Texas United States 77802
42 Pfizer Investigational Site Longview Texas United States 75605
43 Pfizer Investigational Site San Antonio Texas United States 78213
44 Pfizer Investigational Site San Antonio Texas United States 78229
45 Pfizer Investigational Site Arlington Virginia United States 22205
46 Pfizer Investigational Site Spokane Washington United States 99216

Sponsors and Collaborators

  • Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00418782
Other Study ID Numbers:
  • A6341008
First Posted:
Jan 5, 2007
Last Update Posted:
Dec 5, 2018
Last Verified:
Dec 1, 2018
Additional relevant MeSH terms:
Osteoarthritis
Naproxen

Study Results

No Results Posted as of Dec 5, 2018