Recruiting
Phase 2

Celecoxib

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT00597415

Conditions

Osteoarthritis of the Knee

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

celecoxib

placebo

Study Details

Brief summary:

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

Conditions

Osteoarthritis of the Knee

Study ID

NCT00597415

Start date

Dec, 2004

Status verified date

Dec, 2007

Completion date

Mar, 2008

Anticipated

Primary completion date

Feb, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

1. NSAIDs or COX-2 specific inhibitors
2. Analgesics except rescue medication within 24 hours of a study visit
3. Anticoagulants
4. Lithium
5. Glucosamine or chondroitin sulfate are excluded unless on stable dose for at least 3 months

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: A 1

A 1=placebo

active comparator: A 2

A 2=celecoxib

Interventions

celecoxib

celecoxib 200mg

placebo

placebo

Primary outcome measure

  • The primary endpoint is the time to onset of moderate and severe pain. The mean change in time to onset of moderate and sever pain between the first and second walks will be compared using paired t-tests. [ Time Frame: Visits 2 and 3 ]

Central Contacts and Locations

Central contacts

Michelle Wallette, CMA, CCRC

216-591-1443michelle.wallette@uhhospitals.org

Mary Lesko, CNP

216-591-1443mary.lesko@uhhospitals.org

Locations

University Hospitals Case Medical Center

Recruiting

Beachwood, Ohio, United States, 44122

Principal Investigator:

Nora G Singer, MD

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jan 18, 2008

Last verified

Dec, 2007

Keywords

  • Osteoarthritis
  • Knee pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2008-01-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.