Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee - Full Text View

Sponsored by:	NicOx
Information provided by:	NicOx
ClinicalTrials.gov Identifier:	NCT00504127

Purpose

To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis

Condition	Intervention	Phase
Osteoarthritis	Drug: Naproxcinod	Phase III

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, 53 Weeks Study on Analgesic Efficacy and Safety of Naproxcinod (HCT 3012): 26-Week, Randomized, Parallel-Group, Double-Blind, Placebo (13 Weeks)- and Naproxen (26 Weeks)-Controlled, Multicenter Study of Naproxcinod (375 mg Bid and 750 mg Bid) With a 26-Week Naproxen-Controlled Safety Follow-up in Subjects With Osteoarthritis of the Knee, and a 1-Week Post-Treatment Safety Follow-up

Further study details as provided by NicOx:

Primary Outcome Measures:

To show that Naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the knee [ Time Frame: 13 weeks ]

Estimated Enrollment:	1020
Study Start Date:	April 2007

Detailed Description:

This is a 53 week study consisting in a 26 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen. The first 26 weeks will be followed by a naproxen-controlled treatment period up to 52 weeks and a 1-week post-treatment safety follow-up.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and Woman (40 or older) with a diagnosis of primary OA of the knee.
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 anti-coagulant
Clinical relevant abnormal ECG
A history of alcohol or drug abuse
Candidates for imminent joint replacement
Participation within 30 days prior to screening in another investigational study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504127

Show 84 Study Locations

Sponsors and Collaborators

NicOx

More Information

NicOx web-site This link exits the ClinicalTrials.gov site

Study ID Numbers:	HCT 3012-X-302
Study First Received:	July 17, 2007
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00504127
Health Authority:	United States: Food and Drug Administration

Keywords provided by NicOx:

Arthritis
Degenerative

Study placed in the following topic categories:

Nitric Oxide
Osteoarthritis, Knee
Naproxen
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Naproxen-n-butyl nitrate
Rheumatic Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Agents
Pharmacologic Actions
Nitric Oxide Donors

ClinicalTrials.gov processed this record on January 16, 2009