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

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ClinicalTrials.gov Identifier: NCT00418782
Recruitment Status : Terminated (Results of interim analysis indicate lack of efficacy when compared to placebo.)
First Posted : January 5, 2007
Last Update Posted : December 5, 2018
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 4, 2007
First Posted Date  ICMJE January 5, 2007
Last Update Posted Date December 5, 2018
Study Start Date  ICMJE January 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2008)
  • 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 [ Time Frame: ongoing ]
  • The primary endpoint is the change from Baseline (Day 1) to Week 2 (Day 14) in the WOMAC Pain domain score. [ Time Frame: Day 1-14 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2007)
  • The primary endpoint is the change from Baseline (Day 1) to Week 2 (Day 14) in the WOMAC Pain domain score.
  • 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
Change History Complete list of historical versions of study NCT00418782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2008)
  • 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; [ Time Frame: (Days 1 to 6) ]
  • Patient's Global Impression of Change (PGIC) at Week 2; [ Time Frame: Week 2 ]
  • The change from Baseline to Weeks 1 and 2 in the Patient's Global Assessment of Arthritic Condition; [ Time Frame: Baseline to Weeks 1 and 2 ]
  • The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score; [ Time Frame: Day 7 ]
  • The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Stiffness domain score; [ Time Frame: Days 7 and 14 ]
  • The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Physical Function domain score; [ Time Frame: Days 7 and 14 ]
  • The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Total Score by simple summation; [ Time Frame: Days 7 and 14 ]
  • The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Importance Weighted Total Score; [ Time Frame: Days 7 and 14 ]
  • The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: Weeks 1 and 2 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2007)
  • The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score
  • The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Stiffness domain score
  • The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Physical Function domain score
  • The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Total Score by simple summation;
  • The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Importance Weighted Total Score;
  • 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;
  • Patient's Global Impression of Change (PGIC) at Week 2;
  • The change from Baseline to Weeks 1 and 2 in the Patient's Global Assessment of Arthritic Condition;
  • The change from Baseline to Weeks 1 and 2 in the Patient’s Assessment of Arthritis Pain (VAS).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: naproxen
  • Drug: CE-224535
  • Drug: placebo
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: naproxen
  • Experimental: 2
    Intervention: Drug: CE-224535
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 29, 2008)
212
Original Enrollment  ICMJE
 (submitted: January 4, 2007)
300
Actual Study Completion Date  ICMJE August 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00418782
Other Study ID Numbers  ICMJE A6341008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP