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Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00541489
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : February 20, 2009
Sponsor:
Information provided by:
NicOx

Study Description
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Brief Summary:
To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Osteoarthritis, Hip Drug: Naproxcinod Drug: Naproxen Drug: Placebo Phase 3

Detailed Description:
This is a 13 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the Hip
Study Start Date : June 2007
Actual Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
bid
Active Comparator: 2
Naproxen 500 mg
 Drug: Naproxen
500 mg, bid
Experimental: 3
Naproxcinod 750 mg
 Drug: Naproxcinod
750 mg, bid


Outcome Measures
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Primary Outcome Measures :
  1. The primary objective of this study is to show that Naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the hip

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women (40 or older) with a diagnosis of primary OA of the hip
  • Must be a current chronic user of NSAIDS or acetaminophen
  • Must discontinue all analgesic therapy at Screening

Exclusion Criteria:

  • Uncontrolled Hypertension or Diabetes
  • Hepatic or renal impairment
  • Current or expected use of anticoagulant
  • Clinically relevant abnormal ECG
  • A history of alcohol or drug abuse
  • Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
  • Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy
  • Candidates for imminent joint replacement
  • Participation within 30 days prior to screening in another investigational study
Contacts and Locations
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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): NCT00541489


Locations
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United States, Alabama
Mobile, Alabama, United States, 36608
Montgomery, Alabama, United States, 36106
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Chandler, Arizona, United States, 85224
Mesa, Arizona, United States, 85213
Phoenix, Arizona, United States, 85016
United States, California
Fair Oaks, California, United States, 95628
San Diego, California, United States, 92120
Santa Barbara, California, United States, 93111
United States, Colorado
Northglenn, Colorado, United States, 80234
United States, Florida
Coral Gables, Florida, United States, 33134
Daytona Beach, Florida, United States, 32117
Deland, Florida, United States, 32720
Fort Meyers, Florida, United States, 33916
Jupiter, Florida, United States, 33458
United States, Kentucky
Louisville, Kentucky, United States, 40291
United States, Massachusetts
Peabody, Massachusetts, United States, 01960
United States, Michigan
Kalamazoo, Michigan, United States, 49009
Saginaw, Michigan, United States, 48602
United States, New Jersey
Berlin, New Jersey, United States, 08009
Dover, New Jersey, United States, 07801
United States, New York
Rochester, New York, United States, 14609
United States, Ohio
Cincinnati, Ohio, United States, 45224
Cleveland, Ohio, United States, 44122
Franklin, Ohio, United States, 45005
United States, Oklahoma
Bethany, Oklahoma, United States, 73008
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
Penndel, Pennsylvania, United States, 19047
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Anderson, South Carolina, United States, 29621
Columbia, South Carolina, United States, 29204
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Texas
Austin, Texas, United States, 78705
Nederland, Texas, United States, 77627
San Antonio, Texas, United States, 78217
United States, Virginia
Newport News, Virginia, United States, 23606
Canada, British Columbia
Burnaby, British Columbia, Canada, V5G 1T4
Coquitlam, British Columbia, Canada, V3K 3P4
Vancouver, British Columbia, Canada, V5Z 1K3
Canada, Ontario
Corunna, Ontario, Canada, N0N 1G0
Kitchener, Ontario, Canada, N2M 5N6
Mississauga, Ontario, Canada, L4T 4J2
Newmarket, Ontario, Canada, L3Y 5G8
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4P 3X1
Saskatoon, Saskatchewan, Canada, S7K 3H3
Canada
Quebec, Canada, G1V 3M7
Sponsors and Collaborators
NicOx
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00541489    
Other Study ID Numbers: HCT3012-X-303
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009
Keywords provided by NicOx:
Osteoarthritis
Osteoarthritis, Hip
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Naproxen-n-butyl nitrate
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
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nitric Oxide Donors