Trial Information
Summary: Do you suffer from knee pain due to osteoarthritis? If so, you may be eligible to take part in a clinical study testing the effectiveness of an investigational drug in treating knee pain due to osteoarthritis.
A randomized, double-blind clinical study wants to test the
effectiveness of a pain medicine in order to treat knee pain due to
osteoarthritis.
Patients cannot take part in the study if they have any previous
diagnosis of psychosis, bipolar disorder, schizoaffective disorder
or have a history of substance abuse or dependence within the past
year, excluding nicotine and caffeine.
Patients must be at least 40 years of age and meet the American
College of Rheumatology clinical and radiographic criteria for the
diagnosis of OA of the knee with pain for at least 14 days per
month for 3 months prior to study entry.
Your participation in this study is expected to last up to 15
weeks after screening is complete. Up to 230 subjects will be
participating in this study at about 27 study sites in the United
States.
Compensation for participation includes $31 per visit (up to a
total of $186.00) to reimburse for transportation, parking, meal,
or other expenses related to the study.
Patient Inclusion Criteria
- Patients must be at least 40 years with pain in the knee(s) for
at least 14 days of each month for 3 months prior to study
entry.
- Clinical diagnosis of osteoarthritis osteophytes with
radiographic evidence and one of the following: >50 yrs or
<30 minutes morning stiffness or Crepitus.
- Patient cannot have received intrarticular hyaluranoate or
steroids, joint lavage, or invasive treatment to the index knee in
past 6 months.
- No knee arthoscopy of index knee within past year.
- Subject must also be ambulatory
Patient Exclusion Criteria
- Patient will be excluded from the study if any of the following
criteria apply:
- Have received treatment within the last 30 days with a drug
that has not received regulatory approval for any indication at the
time of study entry.
- Have any previous diagnosis of psychosis, bipolar disorder, or
schizoaffective disorder.
- Have major depressive disorder as determined using depression
module of the Mini International Neuropsychiatric Interview
(MINI).
- Have a history of substance abuse or dependence within the past
year, excluding nicotine and caffeine.
For more information,
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Contact:
Rachel Waldrop, Director of Clinical Research
Health Research Institute
1044 S.W. 44th Street, Suite 403
Oklahoma City, OK 73109
Telephone: 405-616-4888
Fax: 405-616-4885
Email:
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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Trial listings updated: June 1, 2008 at 5:46:33 AM