A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee
This study has been terminated.
(Met criteria for study futility at interim analysis)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00483977
First received: June 6, 2007
Last updated: April 22, 2011
Last verified: April 2011
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Purpose
The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: Oxycodone Drug: Placebo Drug: PF-000592379 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from baseline in the pain score averaged over the last week of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Patient Global Impression of Change [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Patients Global Assessment of Osteoarthritis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetic trough levels [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 113 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Oxycodone |
Drug: Oxycodone
Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo: oral for 2 weeks.
|
| Experimental: PF-00592379 |
Drug: PF-000592379
PF-00592379: oral, 30 mg, once a day for 2 weeks
|
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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483977
Locations
| United States, Alabama | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85741 | |
| United States, California | |
| Pfizer Investigational Site | |
| Carmichael, California, United States, 95608 | |
| Pfizer Investigational Site | |
| Fair Oaks, California, United States, 95628 | |
| Pfizer Investigational Site | |
| Orangevale, California, United States, 95662 | |
| Pfizer Investigational Site | |
| Roseville, California, United States, 95661 | |
| Pfizer Investigational Site | |
| Sacramento, California, United States, 95825 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Boca Raton, Florida, United States, 33486 | |
| Pfizer Investigational Site | |
| DeLand, Florida, United States, 32720 | |
| Pfizer Investigational Site | |
| Hollywood, Florida, United States, 33021 | |
| Pfizer Investigational Site | |
| Longwood, Florida, United States, 32779 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33186 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40213 | |
| Pfizer Investigational Site | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89146 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10022-1009 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Durham, North Carolina, United States, 27704 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45227 | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23294 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00483977 History of Changes |
| Other Study ID Numbers: | A7771010 |
| Study First Received: | June 6, 2007 |
| Last Updated: | April 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Oxycodone Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 23, 2013