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

NCT00689273 | Completed Phase 2 Results DMC

• 1 other identifier: A9421006
• Study Type: interventional
• Target: 159
• Locations: 2 countries
• Sites: 22

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

PF-04136309 CCR2 osteoarthritic pain knee; phase 2 placebo multicenter double-blind placebo-controlled

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Domain Score at Week 2

  WOMAC: self-administered, disease-specific 24 item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness, and physical function in participants with osteoarthritis (OA) of the hip and/or knee. It consists of 3 domains: pain, stiffness and physical function. WOMAC pain domain consists of 5 questions scored on 5 point Likert scale (0=minimum pain to 4=maximum pain) where higher score indicates higher pain. It assesses amount of pain experienced due to OA in the study joint in past 48 hours. Total possible pain domain score calculated by addition of scores of each 5 questions ranged from: 0 (minimum) - 20 (maximum), higher scores indicate higher pain.

  Baseline, Week 2

Secondary Outcomes (9)

• Change From Baseline in WOMAC Pain Domain Score at Week 1

  Baseline, Week 1

• Change From Baseline in WOMAC Stiffness Domain Score at Week 1 and Week 2

  Baseline, Weeks 1, 2

• Change From Baseline in WOMAC Physical Function Domain Score at Week 1 and Week 2

  Baseline, Weeks 1, 2

• Change From Baseline in WOMAC Total Score at Week 1 and Week 2

  Baseline, Weeks 1, 2

• Change From Baseline in WOMAC Importance Weighted Total Score at Week 1 and Week 2

  Baseline, Weeks 1, 2

Other Outcomes (11)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Baseline up to 30 days after last dose of study drug (up to Day 44)

• Number of Participants With Treatment Emergent Treatment Related AEs and SAEs

  From Baseline up to 30 days after last dose of study drug (up to Day 44)

• Number of Participants Who Discontinued Due to Treatment Emergent AEs and Treatment Emergent Treatment Related AEs

  From Baseline up to 30 days after last dose of study drug (up to Day 44)

Study Arms (2)

PF-04136309

EXPERIMENTAL

Drug: PF-04136309

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PF-04136309 DRUG

125 mg capsules. Dose will be 4 capsules BID for 2 weeks for a total of 500 mg for each dosing interval.

PF-04136309

Placebo DRUG

Placebo will be matched to PF-04136309. Dose, frequency, and duration same as PF-04136309.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (22)

University Clinical Research-DeLand, LLC

DeLand, Florida, 32720, United States

Location

Arthritis & Rheumatic Care Center

South Miami, Florida, 33143, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Diagnostic Imaging Centers

Overland Park, Kansas, 66212, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Commonwealth Biomedical Research, LLC

Madisonville, Kentucky, 42431, United States

Location

Covenant Health and Wellness Center

Chesterfield, Missouri, 63005, United States

Location

Metro Imaging St. Peters

City of Saint Peters, Missouri, 63376, United States

Location

Metro Imaging West County

Creve Coeur, Missouri, 63141, United States

Location

Analgesic Development Limited

New York, New York, 10022-1009, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Statcare

Warwick, Rhode Island, 02886, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

South Texas Radiology Group

San Antonio, Texas, 78229, United States

Location

Commonwealth Orthopaedics and Rehabilitation PC

Arlington, Virginia, 22205, United States

Location

IntegraTrials, LLC

Arlington, Virginia, 22205, United States

Location

United Hospital Center Clinical Trials Office

Clarksburg, West Virginia, 26301, United States

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

PF-04136309

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 3, 2008
• Study Start: August 5, 2008
• Primary Completion: November 27, 2008
• Study Completion: November 27, 2008
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

US (18); KR (4)