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

• ClinicalTrials.gov Identifier: NCT00689273
• Recruitment Status: Completed
• First Posted: June 3, 2008
• Last Update Posted: October 1, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: May 30, 2008
• First Posted Date: June 3, 2008
• Last Update Posted Date: October 1, 2012
• Study Start Date: August 2008
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 30, 2008): 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. ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 22, 2008)

• 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). ]
• 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. ]
• 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. ]
• The change from Baseline to Weeks 1 and 2 in the WOMAC Physical Function domain score. [ Time Frame: Baseline through Weeks 1 and 2. ]
• The change from Baseline to Weeks 1 and 2 in the WOMAC Stiffness domain score. [ Time Frame: Baseline through Weeks 1 and 2. ]
• 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) ]

Original Secondary Outcome Measures (submitted: May 30, 2008)

• The change from Baseline to Weeks 1 and 2 in the WOMAC Stiffness domain score. [ Time Frame: Baseline through Weeks 1 and 2. ]
• 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. ]
• 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). ]
• 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. ]
• The change from Baseline to Weeks 1 and 2 in the WOMAC Physical Function domain score. [ Time Frame: Baseline through Weeks 1 and 2. ]
• 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) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Osteoarthritis, Knee

Intervention

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

Study Arms

• Experimental: PF-04136309
  Intervention: Drug: PF-04136309
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 25, 2012): 157
• Original Estimated Enrollment (submitted: May 30, 2008): 152
• Actual Study Completion Date: November 2008
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of, United States

Administrative Information

• NCT Number: NCT00689273
• Other Study ID Numbers: A9421006
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

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

• PRS Account: Pfizer
• Verification Date: September 2012