A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee

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NCT00483977

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Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
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

- Knee Pain due to osteoarthritis

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


- Pregnant


- Participation in a clinical trial for an investigational drug and/or agent within 30
days prior to baseline


- History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee
within the past year

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Advanced Information
Descriptive Information
Brief Title  ICMJE A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee
Official Title  ICMJE A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicentre Study To Assess The Efficacy And Tolerability Of PF-00592379 In Patients With Moderate To Severe Pain Due To Osteoarthritis
Brief Summary The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.
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: Oxycodone
    Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks
  • Drug: Placebo
    Placebo: oral for 2 weeks.
  • Drug: PF-000592379
    PF-00592379: oral, 30 mg, once a day for 2 weeks
Study Arms  ICMJE
  • Active Comparator: Oxycodone
    Intervention: Drug: Oxycodone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-00592379
    Intervention: Drug: PF-000592379
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: September 30, 2008)		113
Original Enrollment  ICMJE
 (submitted: June 6, 2007)		225
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (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
  • Knee Pain due to osteoarthritis

Exclusion Criteria:

  • Pregnant
  • Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline
  • History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year
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 NCT00483977
Other Study ID Numbers  ICMJE A7771010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2011

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