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A Study in the Treatment of Osteoarthritis Knee Pain | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study in the Treatment of Osteoarthritis Knee Pain

A Phase 2 Study of the Effects of LY545694, an iGluR5 Antagonist, in the Treatment of Subjects With Osteoarthritis Knee Pain

NCT00790790•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

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.
+14 more criteria

Locations (10)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Spring Valley, California, United States

DeLand, Florida, United States

South Miami, Florida, United States

St Louis, Missouri, United States

Edison, New Jersey, United States

Hato Rey, Puerto Rico

Brasov, Romania

Bucharest, Romania

Iași, Romania

Târgu Mureş, Romania

Key Dates

Start Date

November 1, 2008

Primary Completion Date

January 1, 2010

Completion Date

January 1, 2010

Last Updated

April 17, 2012

Enrollment

147

ACTUAL participants

Conditions

Osteoarthritis Knee Pain

Interventions

Placebo

DRUG

LY545694 49 mg

DRUG

LY545694 105 mg

DRUG

Duloxetine Versus Placebo for Osteoarthritis Knee Pain

NCT00408421

Osteoarthritis Knee Pain

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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