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

NCT00689273

Last updated date
Study Location
Pfizer Investigational Site
DeLand, Florida, 32720, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Knee
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Osteoarthritis, KneeRandomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee
NCT00689273
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Advanced Information
Descriptive Information
Brief Title  ICMJE Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • 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  ICMJE
  • Experimental: PF-04136309
    Intervention: Drug: PF-04136309
  • Placebo Comparator: Placebo
    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 Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2012)
157
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2008)
152
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  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 Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00689273
Other Study ID Numbers  ICMJE A9421006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2012

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