Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00689273
First received: May 30, 2008
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

To evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics in patients with osteoarthritic pain of the knee. The most painful knee joint will be identified as the index joint at screening, and this joint will be used for all pain assessments throughout the study.


Condition Intervention Phase
Osteoarthritis, Knee
Drug: PF-04136309
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 2-Week, Randomized, Double Blind, Placebo Controlled, Parallel-Group, Phase 2, Multicenter Study Of Pf-04136309 In Subjects With Osteoarthritic Pain Of The Knee

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary efficacy endpoint is the change from Baseline (Day 1) to Week 2 (Day 14) in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain domain score. [ Time Frame: Baseline through Week 2. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change from Baseline(averaging from Day -6 to Day 0) to each day (Days 1 to 14) using an 11 point numeric rating scale (NRS) from 0-10 on a daily pain diary. [ Time Frame: Baseline through each day ( Days 1 to 14). ] [ Designated as safety issue: No ]
  • The change from Baseline to Weeks 1 and 2 in the Patient's Global Assessment of Arthritic Condition. [ Time Frame: Baseline through Weeks 1 and 2. ] [ Designated as safety issue: No ]
  • The change from Baseline (averaging from Day -6 to Day 0) at week 1 (averaging from Day 1 in the evening to Day 7) and at week 2 ( averaging from Day 8 to day 14) using an 11 point numeric rating scale (NRS) from 0-10 on a daily pain diary. [ Time Frame: Baseline through Weeks 1 and 2. ] [ Designated as safety issue: No ]
  • The change from Baseline to Weeks 1 and 2 in the WOMAC Physical Function domain score. [ Time Frame: Baseline through Weeks 1 and 2. ] [ Designated as safety issue: No ]
  • The change from Baseline to Weeks 1 and 2 in the WOMAC Stiffness domain score. [ Time Frame: Baseline through Weeks 1 and 2. ] [ Designated as safety issue: No ]
  • The change from Baseline to Week 1 (Day 7) in theWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain domain score. [ Time Frame: Baseline through Week 1 (Day 7) ] [ Designated as safety issue: No ]

Enrollment: 157
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04136309 Drug: PF-04136309
125 mg capsules. Dose will be 4 capsules BID for 2 weeks for a total of 500 mg for each dosing interval.
Placebo Comparator: Placebo Drug: Placebo
Placebo will be matched to PF-04136309. Dose, frequency, and duration same as PF-04136309.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of any race, between the ages of 18 and 75 years inclusive
  • Female subjects must be of non-childbearing potential and have a negative pregnancy test at Screening.
  • Osteoarthritis of the knee of at least 6 months duration and meeting the American College of Rheumatology Criteria. For radiographic criteria the Xray must have been taken within the last 5 years. If none is available, one should be taken and the diagnostic criteria confirmed prior to randomization.
  • Willing and able to discontinue all current analgesic therapy, including OTC pain medications and topical analgesics for OA pain, for period beginning with washout phase (lasting 2 days or 5 half-lives of patient's current analgesic medication prior to Day -6) and continuing for the entire duration of study. As an exception, acetaminophen may be used for non-joint related pain at doses ≤1 g/day at the discretion of a qualified member of the study team.
  • If a subject has evidence or a history of clinically significant endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological disease, the investigator must confirm that the disease is stable (at least 4 weeks) and under control.
  • QTc interval ≤450 msec and a PR interval ≤210 msec on Screening ECG.

Exclusion Criteria:

  • Pregnant or lactating females, and females of childbearing potential.
  • Arthroscopy performed on index knee within 1 year of screening.
  • Active depression as defined by or meeting The Hospital Anxiety and Depression Scale (HADS) of >10.
  • Unwillingness to refrain from consumption of grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until completion of the study.
  • First degree or higher AV block, defined as PR interval >210 msecs, bundle branch block, fascicular block or intraventricular conduction delay or clinically relevant abnormality on screening ECG.
  • Active malignancy of any type or history of a malignancy within 10 years (with the exception of subjects with a history of treated basal cell carcinoma).
  • Symptomatic OA of the hip ipsilateral to index knee which the patient considers more painful than the knee.
  • Use of prohibited medications as listed below, in the absence of appropriate washout period. The following analgesic agents must be discontinued within 48 hours or 5 half lives of the analgesic being washed out prior to the baseline period (Day -6 to Day 0);

    • NSAIDs and selective COX-2 inhibitors;
    • Acetaminophen ( as an exception acetaminophen may be used for non-joint related pain at doses ≤1g/day);
    • Opioids.
    • Oral or I/M corticosteroids within 4 weeks prior to screening. I/A steroids within 12 weeks prior to baseline in study joint or any other joints within 4 weeks prior to baseline, or I/A hyaluronic acid within 24 weeks prior to baseline;
    • Use of concomitant medications that are CYP3A inhibitors or CYP3A inducers, or that are P-glycoprotein substrates within 48 hours or 5 half lives prior to baseline.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689273

Locations
United States, Florida
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
United States, Kentucky
Pfizer Investigational Site
Madisonville, Kentucky, United States, 42431
United States, Missouri
Pfizer Investigational Site
Chesterfield, Missouri, United States, 63005
Pfizer Investigational Site
Creve Coeur, Missouri, United States, 63141
Pfizer Investigational Site
St. Peters, Missouri, United States, 63376
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10022-1009
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45242
United States, Rhode Island
Pfizer Investigational Site
Warwick, Rhode Island, United States, 02886
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Pfizer Investigational Site
Arlington, Virginia, United States, 22205
United States, West Virginia
Pfizer Investigational Site
Clarksburg, West Virginia, United States, 26301
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00689273     History of Changes
Other Study ID Numbers: A9421006
Study First Received: May 30, 2008
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PF-04136309 CCR2 osteoarthritic pain knee, phase 2 placebo multicenter double-blind placebo-controlled

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014