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

NCT00597415 | Unknown Phase 2 DMC

• 2 other identifiers: Pfizer walking modelUH IRB 06-04-41
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Osteoarthritis; Knee pain

Outcome Measures

Primary Outcomes (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.

  Visits 2 and 3

Secondary Outcomes (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.

  Visits 2 and 3

Study Arms (2)

A 1

PLACEBO COMPARATOR

A 1=placebo

Drug: placebo

A 2

ACTIVE COMPARATOR

A 2=celecoxib

Drug: celecoxib

Interventions

celecoxib DRUG

celecoxib 200mg

Also known as: Celebrex

A 2

placebo DRUG

placebo

Also known as: inactive capsule

A 1

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Beachwood, Ohio, 44122, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nora G Singer, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Wallette, CMA, CCRC

CONTACT

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

Mary Lesko, CNP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: December 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 18, 2008

Record last verified: 2007-12

Locations

US (1)