A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee
NCT00981357
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray
- Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study)
- Subjects can be male or female between the ages of 18 and 75 years inclusive, but female subjects must not be able become pregnant
- Subjects must not have any condition or medical history that might interfere with
their ability to complete the study assessments
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Boston, Massachusetts
- Cleveland, Ohio
- Funabashi, Chiba
- Sakura, Chiba
- Chikushi-gun, Fukuoka
- Iizuka, Fukuoka
- Kurume, Fukuoka
- Yame, Fukuoka
- Chitose, Hokkaido
- Sapporo, Hokkaido
- Kamakura, Kanagawa
- Yokohama, Kanagawa
- Isahaya, Nagasaki
- Hirakata, Osaka
- Kanzaki-gun, Saga
- Karatsu, Saga
- Ogi-gun, Saga
- Itabashi-ku, Tokyo
- Setagaya-ku, Tokyo
- Shinjuku-Ku, Tokyo
- Taito-ku, Tokyo
- Yoyogi Shibuya-ku, Tokyo
- Saga,
- Tokyo,
- Bad Muender,
- Beckum,
- Berlin,
- Berlin,
- Berlin,
- Berlin,
- Ostseebad Damp,
- Schwerin,
- Stade,
- Tostedt,
- Weener,
- Barcelona,
- Barcelona,
- Cadiz,
- Guadalajara,
- Madrid,
- Madrid,
- Madrid,
- Oviedo,
- Sevilla,
- Valencia,
- Chelmsly Wood, Birmingham
- Truro, Cornwall
- Chorley, Lancs
- Liverpool, Lancs
- Cannock, Mid Staffordshire
- Addlestone, Surrey
- Huddersfield,
- London,
- London,
- Manchester,
- Newcastle Upon Tyne,
- Wigan,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee | |||
Official Title ICMJE | A Phase 2a Randomized, Double-blinded, Double Dummy, Placebo And Active Controlled, Two-way Cross-over, Flare-enriched Multi-centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A Fatty Acid Amide Hydrolase (Faah) Inhibitor Pf-04457845 In Patients With Osteoarthritis Of The Knee. | |||
Brief Summary | Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme in animals and healthy human volunteers. The purpose of this study is to evaluate whether PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and whether this results in these patients experiencing less pain. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Osteoarthritis, Knee | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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 | 76 | |||
Original Estimated Enrollment ICMJE | 130 | |||
Actual Study Completion Date ICMJE | May 2010 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 | Canada, Sweden, United States | |||
Removed Location Countries | South Africa | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00981357 | |||
Other Study ID Numbers ICMJE | B0541004 2009-014734-16 ( EudraCT Number ) | |||
Has Data Monitoring Committee | No | |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | September 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |