Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip
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
1 other identifier
interventional
800
2 countries
48
Brief Summary
To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 8, 2007
CompletedFirst Posted
Study publicly available on registry
October 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedFebruary 20, 2009
February 1, 2009
1.3 years
October 8, 2007
February 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Study Arms (3)
1
PLACEBO COMPARATOR2
ACTIVE COMPARATORNaproxen 500 mg
3
EXPERIMENTALNaproxcinod 750 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NicOxlead
Study Sites (48)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Montgomery, Alabama, 36106, United States
Unknown Facility
Tuscaloosa, Alabama, 35406, United States
Unknown Facility
Chandler, Arizona, 85224, United States
Unknown Facility
Mesa, Arizona, 85213, United States
Unknown Facility
Phoenix, Arizona, 85016, United States
Unknown Facility
Fair Oaks, California, 95628, United States
Unknown Facility
San Diego, California, 92120, United States
Unknown Facility
Santa Barbara, California, 93111, United States
Unknown Facility
Northglenn, Colorado, 80234, United States
Unknown Facility
Coral Gables, Florida, 33134, United States
Unknown Facility
Daytona Beach, Florida, 32117, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Fort Meyers, Florida, 33916, United States
Unknown Facility
Jupiter, Florida, 33458, United States
Unknown Facility
Louisville, Kentucky, 40291, United States
Unknown Facility
Peabody, Massachusetts, 01960, United States
Unknown Facility
Kalamazoo, Michigan, 49009, United States
Unknown Facility
Saginaw, Michigan, 48602, United States
Unknown Facility
Berlin, New Jersey, 08009, United States
Unknown Facility
Dover, New Jersey, 07801, United States
Unknown Facility
Rochester, New York, 14609, United States
Unknown Facility
Cincinnati, Ohio, 45224, United States
Unknown Facility
Cleveland, Ohio, 44122, United States
Unknown Facility
Franklin, Ohio, 45005, United States
Unknown Facility
Bethany, Oklahoma, 73008, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Penndel, Pennsylvania, 19047, United States
Unknown Facility
Warwick, Rhode Island, 02886, United States
Unknown Facility
Anderson, South Carolina, 29621, United States
Unknown Facility
Columbia, South Carolina, 29204, United States
Unknown Facility
Kingsport, Tennessee, 37660, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Nederland, Texas, 77627, United States
Unknown Facility
San Antonio, Texas, 78217, United States
Unknown Facility
Newport News, Virginia, 23606, United States
Unknown Facility
Burnaby, British Columbia, V5G 1T4, Canada
Unknown Facility
Coquitlam, British Columbia, V3K 3P4, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1K3, Canada
Unknown Facility
Corunna, Ontario, N0N 1G0, Canada
Unknown Facility
Kitchener, Ontario, N2M 5N6, Canada
Unknown Facility
Mississauga, Ontario, L4T 4J2, Canada
Unknown Facility
Newmarket, Ontario, L3Y 5G8, Canada
Unknown Facility
Toronto, Ontario, M9W 4L6, Canada
Unknown Facility
Québec, Quebec, G1V 3M7, Canada
Unknown Facility
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Unknown Facility
Regina, Saskatchewan, S4P 3X1, Canada
Unknown Facility
Saskatoon, Saskatchewan, S7K 3H3, Canada
Related Publications (1)
Baerwald C, Verdecchia P, Duquesroix B, Frayssinet H, Ferreira T. Efficacy, safety, and effects on blood pressure of naproxcinod 750 mg twice daily compared with placebo and naproxen 500 mg twice daily in patients with osteoarthritis of the hip: a randomized, double-blind, parallel-group, multicenter study. Arthritis Rheum. 2010 Dec;62(12):3635-44. doi: 10.1002/art.27694.
PMID: 20722026DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 8, 2007
First Posted
October 10, 2007
Study Start
June 1, 2007
Primary Completion
September 1, 2008
Last Updated
February 20, 2009
Record last verified: 2009-02