Efficacy of Celecoxib Vs Placebo to Prevent Pain in a Paced Walk

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2004 by University Hospitals of Cleveland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00194090
First received: September 13, 2005
Last updated: NA
Last verified: July 2004
History: No changes posted
  Purpose

A paced 20-minute walk is a reproducible model for acute pain in knee osteoarthritis


Condition Intervention Phase
Knee Osteoarthritis
Drug: celecoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, 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:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • time to onset of severe pain

Secondary Outcome Measures:
  • time to onset of moderate pain

Estimated Enrollment: 40
Study Start Date: June 2004
Estimated Study Completion Date: September 2005
Detailed Description:

This is a randomizd, placbo-controlled, crossover trial comparing a single dose of celecoxib to placebo measuring the time to onset of acute pain in a paced 20-minute walk.

40 subjects will be enrolled

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Knee osteoarthritis by ACR clinical criteria Pain of at least 40 mm by VAS at baseline

-

Exclusion Criteria:

Non-pregant, non-lactating Able to stop active arthritis medication for washout Cardiovascular risk factors Abnormal EKG -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194090

Contacts
Contact: Michele M Hooper, MD, MS (216) 591-1443 ext 13 michele.hooper@uhhs.com
Contact: Michelle Wallette, MA (216) 591-1443 ext 15 michelle.wallette@uhhs.com

Locations
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Michelle Wallette, MA    216-591-1443 ext 14    michelle.wallette@uhhs.com   
Contact: Michele M Hooper, MD, MS    (216) 591-1443 ext 13    michele.hooper@uhhs.com   
Principal Investigator: Michele M Hooper, MD, MS         
Sponsors and Collaborators
University Hospitals of Cleveland
Pfizer
Investigators
Principal Investigator: Michele M Hooper, MD, MS University Hospitals of Cleveland
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00194090     History of Changes
Other Study ID Numbers: 06-04-41
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by University Hospitals of Cleveland:
pain
osteoarthritis

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 July 28, 2014