Clinical trial NCT00541489: Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Osteoarthritis, Hip
Keywords: Osteoarthritis
Osteoarthritis, Hip
Lead sponsor: NicOx
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 800
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 the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.

Detailed description: This is a 13 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Fair Oaks
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Northglenn
country: United States
state: Colorado
city: Coral Gables
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Fort Meyers
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Louisville
country: United States
state: Kentucky
city: Peabody
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Berlin
country: United States
state: New Jersey
city: Dover
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Franklin
country: United States
state: Ohio
city: Bethany
country: United States
state: Oklahoma
city: Duncansville
country: United States
state: Pennsylvania
city: Penndel
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Kingsport
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Nederland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Newport News
country: United States
state: Virginia
city: Burnaby
country: Canada
state: British Columbia
city: Coquitlam
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Corunna
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Trois-Rivieres
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
Study officials:
References:
citation: 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.