Efficacy of Celecoxib 200mg in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis of the Knee

In brief

The purpose of this study is to compare the efficacy of celecoxib versus placebo in delaying the onset of pain and improving walking function in subjects with knee Osteoarthritis

Key facts

Study ID

NCT00597415

Run by

University Hospitals Cleveland Medical Center

People needed

30

Starts

2004-12-01

Expected to finish

2008-03-01

Last updated by the study team

2008-01-18

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• If female and of childbearing potential, must be using adequate contraception since last menses and will use adequate contraception during the study,
• Diagnosed as having OA of the knee
• Functional Capacity Classification of I-II (FCC)
• If on active analgesic or anti-inflammatory pain medication, must have VAS pain score>=30mm in signal knee related to walking on a flat surface within the previous 48 hours. Subjects who are not taking any pain medication must have a VAS pain score>=40mm in the signal knee
• At baseline visit, must have a history of pain in the signal knee>=40mm when walking on the flat within the previous 48 hours.
• In the Investigator's opinion, the patient requires and is eligible for therapy with an anti-inflammatory analgesic.
• If on an NSAID or analgesic, patient must have completed a washout period prior to baseline assessments that is a minium of five half lives.
• The patient has provided written informed consent before undergoing any study procedures.

You may not qualify if…

• Diagnosed as having inflammatory arthritis or acute trauma at the index joint.
• Another painful condition that would interfere with his/her ability to walk or to make reasonable assessments of their pain.
• Received an injection of corticosteroid into the signal knee within 3 months; or with a hyaluronan produce in the signal knee within the previous 6 months.
• Requires the use of a cane or other assistive device to complete the walk.
• Known cardiovascular disease which has been symptomatic in the past 12 months
• History of blood clots or is at any increased risk for blood clotting.
• Asthma or any breathing condition which would preclude walking briskly for 20 consecutive minutes or 40 minutes total.
• Has taken any NSAIDs, COX-2 inhibitors, or any analgesic, with the exception of the rescue acetaminophen, within two days prior to Visit 2
• Active malignancies or any type or a malignancy that has recurred within 5 years before enrollment.
• Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, duodenal ulceration within 90 days
• Active GI disease, a chronic or acute renal or hepatic disorder, or a significant coagulation defect.
• Any chronic illness or laboratory abnormalities considered to be clinically significant.
• Received any investigational medication within 30 days
• Known hypersensitivity to celecoxib, NSAIDs, to sulfonamides
• Use of the following drugs:
• NSAIDs or COX-2 specific inhibitors
• Analgesics except rescue medication within 24 hours of a study visit
• Anticoagulants
• Lithium
• Glucosamine or chondroitin sulfate are excluded unless on stable dose for at least 3 months

Where it is running

• University Hospitals Case Medical Center — Beachwood, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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