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

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ClinicalTrials.gov Identifier: NCT00597415
Recruitment Status : Unknown
Verified December 2007 by University Hospitals Cleveland Medical Center.
Recruitment status was:  Recruiting
First Posted : January 18, 2008
Last Update Posted : January 18, 2008
Sponsor:
Information provided by:
University Hospitals Cleveland Medical Center

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

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: celecoxib Drug: placebo Phase 2

Detailed Description:
We have developed a walking model that safely and reproducibly induces pain in subjects with knee OA in a manner that permits the comparison of the effect of different therapies on pain control. In a previous study, we demonstrated that a self-paced 20 minute walk followed by a one-hour rest and a second coordinator-paced 20-minute walk was well tolerated and generated moderate to severe pain in all participants within the time frame of the walk. We will now use this model, but with a crossover design to test the efficacy of celecoxib compared to placebo for the control of knee pain and improvement of walking function.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Crossover Pilot Study of the Efficacy of Celecoxib 200 mg QD in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee.
Study Start Date : December 2004
Estimated Primary Completion Date : February 2008
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Celecoxib
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: A 1
A 1=placebo
Drug: placebo
placebo
Other Name: inactive capsule
Active Comparator: A 2
A 2=celecoxib
Drug: celecoxib
celecoxib 200mg
Other Name: Celebrex



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Secondary endpoints are the distance to onset of moderate to sever pain the the percent responders in each group. Thirty subjects will be studied in this randomized, placebo-controlled, double-blind crossover study. [ Time Frame: Visits 2 and 3 ]


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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597415


Contacts
Contact: Michelle Wallette, CMA, CCRC 216-591-1443 ext 15 michelle.wallette@uhhospitals.org
Contact: Mary Lesko, CNP 216-591-1443 ext 13 mary.lesko@uhhospitals.org

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Beachwood, Ohio, United States, 44122
Principal Investigator: Nora G Singer, MD         
Sub-Investigator: Mary Lesko, CNP         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: Nora G Singer, MD UHCMC

Responsible Party: Nora G. Singer MD, University Hospitals Case Medical Center
ClinicalTrials.gov Identifier: NCT00597415     History of Changes
Other Study ID Numbers: Pfizer walking model
UH IRB 06-04-41
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: January 18, 2008
Last Verified: December 2007

Keywords provided by University Hospitals Cleveland Medical Center:
Osteoarthritis
Knee pain

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents