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

Information source: NicOx
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis

Intervention: Naproxcinod 375 mg bid (Drug); Naproxcinod 750 mg bid (Drug); Naproxen 500 mg bid (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: NicOx

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To show that both doses of Naproxcinod (375 mg twice daily [bid] and 750 mg bid) were superior to placebo in relieving osteoarthritis (OA) signs and symptoms in subjects with OA of the knee at Week 13.

Secondary outcome:

To assess the efficacy of naproxcinod compared to naproxen 500 mg bid in relieving OA signs and symptoms in subjects with OA of the knee

To evaluate the effect on blood pressure (BP) of both doses of naproxcinod, placebo, and naproxen 500 mg bid, as measured by the office BP monitoring in a population of OA subjects

To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach

To assess if there were any radiological changes at Week 52 in naproxcinod compared with naproxen subjects (target joint radiographs were taken at Screening and after 52 weeks of treatment, or if early termination occurred after Week 26)

To compare the general safety and tolerability of both doses of naproxcinod versus naproxen 500 mg bid up to 52 weeks and with one Week post treatment follow up (Week 53)

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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Chandler, Arizona, United States

Tempe, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Anaheim, California, United States

Encino, California, United States

Foothill Ranch, California, United States

Orange, California, United States

Rancho Mirage, California, United States

Riverside, California, United States

Denver, Colorado, United States

Waterbury, Connecticut, United States

Boca Raton, Florida, United States

Brooksville, Florida, United States

Deland, Florida, United States

Jacksonville, Florida, United States

Largo, Florida, United States

Ocala, Florida, United States

Pinellas Park, Florida, United States

St. Petersburg, Florida, United States

Tampa, Florida, United States

Athens, Georgia, United States

Atlanta, Georgia, United States

Marietta, Georgia, United States

Chicago, Illinois, United States

Rockford, Illinois, United States

Prairie Village, Kansas, United States

Wichita, Kansas, United States

Erlanger, Kentucky, United States

Louisville, Kentucky, United States

Baton Rouge, Louisiana, United States

Owings Mills, Maryland, United States

Wellesley HIlls, Massachusetts, United States

Ann Arbor, Michigan, United States

Brooklyn Center, Minnesota, United States

Edina, Minnesota, United States

Florissant, Missouri, United States

St. Louis, Missouri, United States

Rochester, New York, United States

Asheville, North Carolina, United States

Charlotte, North Carolina, United States

Concord, North Carolina, United States

Raleigh, North Carolina, United States

Salisbury, North Carolina, United States

Winston-Salem, North Carolina, United States

Beachwood, Ohio, United States

Columbus, Ohio, United States

Marion, Ohio, United States

Clinton, Oklahoma, United States

Altoona, Pennsylvania, United States

Bensalem, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

West Reading, Pennsylvania, United States

Anderson, South Carolina, United States

Clinton, South Carolina, United States

Goose Creek, South Carolina, United States

Greer, South Carolina, United States

Mt Pleasant, South Carolina, United States

Cordova, Tennessee, United States

Jackson, Tennessee, United States

Kingsport, Tennessee, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Garland, Texas, United States

Houston, Texas, United States

Nederland, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Norfolk, Virginia, United States

Roanoke, Virginia, United States

Virginia Beach, Virginia, United States

Lakewood, Washington, United States

Additional Information

Starting date: April 2007
Last updated: June 16, 2011

Page last updated: August 23, 2015

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