Clinical trial NCT00504127: Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Arthritis
Degenerative
Lead sponsor: NicOx
Sponsor class: INDUSTRY
First posted: 2007-07-19
Enrollment: 1020
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: 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.
timeFrame: 13 weeks
Secondary outcomes:
measure: 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
timeFrame: 52 weeks
measure: 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
timeFrame: 52 weeks
measure: To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach
timeFrame: 52 weeks
measure: 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)
timeFrame: 52 weeks
measure: 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)
timeFrame: 53 weeks
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Encino
country: United States
state: California
city: Foothill Ranch
country: United States
state: California
city: Orange
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Riverside
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Brooksville
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Athens
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Prairie Village
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Erlanger
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Owings Mills
country: United States
state: Maryland
city: Wellesley HIlls
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Brooklyn Center
country: United States
state: Minnesota
city: Edina
country: United States
state: Minnesota
city: Florissant
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Concord
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Beachwood
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Clinton
country: United States
state: Oklahoma
city: Altoona
country: United States
state: Pennsylvania
city: Bensalem
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Clinton
country: United States
state: South Carolina
city: Goose Creek
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Mt Pleasant
country: United States
state: South Carolina
city: Cordova
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Garland
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Nederland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Lakewood
country: United States
state: Washington
Study officials:
References: