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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium AZD 3582

U.S. FDA Resources

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 ]

Enrollment:	1020
Study Start Date:	April 2007
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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

Additional Information:

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

No publications provided

Study ID Numbers:	HCT 3012-X-302
Study First Received:	July 17, 2007
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00504127 History of Changes
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
Cardiovascular Agents
Analgesics
Rheumatic Diseases
Nitric Oxide Donors

Additional relevant MeSH terms:

Osteoarthritis, Knee
Molecular Mechanisms of Pharmacological Action
Musculoskeletal Diseases
Osteoarthritis
Therapeutic Uses
Joint Diseases

Arthritis
Naproxen-n-butyl nitrate
Cardiovascular Agents
Rheumatic Diseases
Pharmacologic Actions
Nitric Oxide Donors

ClinicalTrials.gov processed this record on September 11, 2009