A Study in the Treatment of Osteoarthritis Knee Pain
Condition: Osteoarthritis Knee Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Placebo; LY545694 49 mg; LY545694 105 mg
Intervention description: LY545694 placebo BID po for 5 weeks; LY545694 49 mg BID po for 5 weeks.; LY545694 105 mg BID po for 5 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 147.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an
      effect on pain levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with Osteoarthritis (OA) of the knee based on: 1) Knee pain for at least 14
             days per month for the last 3 months, 2) Osteophytes (bone spurs), 3) And at least 1
             of the following: Over the age of 50, OR morning stiffness in knee for less than 30
             minutes, OR crunching sensation as the knee bends back and forth (crepitus).

          -  Mean score of 4 or greater on the 24-hour average pain score from Visit 2 to Visit 3.

          -  Completion of electronic daily diaries with at least 70% complete between Visit 2 and
             Visit 3.

          -  Taken non-steroidal anti-inflammatory drugs (NSAIDs) less than 15 days over the past
             month AND not taken NSAIDs at least 1 week prior to Visit 3.

          -  Agree to maintain the same activity level throughout the study.

          -  Women who can become pregnant must test negative for pregnancy and agree to utilize
             medically acceptable/reliable birth control during the study and 1 month following the
             last dose of the study.

          -  Competent and freely able to give an informed consent.

          -  Ability to understanding and intelligibly communicate with the investigator.

          -  Judged to be reliable and agree to keep all appointments for clinic visits, tests, and
             procedures required by the protocol.

        Exclusion Criteria:

          -  Knee arthroscopy within past 3 months or any knee joint replacement.

          -  Surgery planned during the trial for the knee to be studied.

          -  Prior synovial fluid analysis showing a white blood cell of 2000 cubic millimeters
             (mm^3) that is indicative of a diagnosis other than OA

          -  Are non-ambulatory or require the use of crutches or a walker. Use of a cane in the
             hand opposite the index knee is acceptable.

          -  Body Mass Index over 40.

          -  Confounding painful condition that may interfere with assessment of the index knee.
             (Knee pain should be the predominant pain. Mild OA of the hands is allowed, for
             instance.)

          -  Diagnosis of inflammatory arthritis (rheumatoid arthritis) or an autoimmune disorder
             (except inactive Hashimoto's thyroiditis).

          -  Received intra-articular hyaluronate or steroids, joint lavage, or other invasive
             therapies to the knee in the past 3 months.

          -  Frequent falls that could result in hospitalization or could compromise response to
             treatment.

          -  Current or previous (within the past 1 year) Axis 1 diagnosis of major depressive
             disorder, mania, bipolar disorder, psychosis, dysthymia, anxiety disorder, alcohol or
             eating disorders.

          -  Serious or unstable cardiovascular, hepatic, renal, respiratory, ophthalmologic,
             gastrointestinal, or hematologic illness, symptomatic peripheral vascular disease, or
             other medical condition that in the opinion of investigator would compromise
             participation or be likely to lead to hospitalization during the course of the study.

          -  Alanine transaminase (ALT) > 2.0 times upper limit of normal at Visit 1, based on
             reference ranges of the central lab.

          -  Prior renal transplant, current renal dialysis, or serum creatinine laboratory value
             >1.5 times upper limit of normal based on the reference ranges of the central lab.

          -  Diagnosis or past history of glaucoma. Subjects with intraocular pressure >24
             millimeters of mercury (mm Hg).

          -  Are taking any excluded medications that cannot be discontinued at Visit 1.

          -  History of substance abuse or dependence within the past year, excluding nicotine and
             caffeine. Have a positive urine drug screen for any substance of abuse or excluded
             medication.

          -  History of recurrent seizures other than febrile seizures.

          -  Are judged by the investigator to be at suicidal risk.

          -  History of frequent and/or severe allergic reactions with multiple medications.

          -  Pregnant or breast-feeding.

          -  Are unwilling/unable to comply with the use of a data collection devices.

          -  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.

          -  Investigator site personnel directly affiliated with this study, and/or their
             immediate families, or Lilly employees.

          -  History of severe delay in stomach emptying (gastroparesis).