Efficacy of Celecoxib 200mg in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee - Full Text View

Sponsor:	University Hospitals of Cleveland
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00597415

Purpose

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	Intervention	Phase
Osteoarthritis of the Knee	Drug: celecoxib Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2004
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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 of Cleveland

Investigators

Principal Investigator:

Nora G Singer, MD

UHCMC

More Information

No publications provided

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
Study First Received:	January 9, 2008
Last Updated:	January 9, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

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

Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012