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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504127
• Other study ID #: HCT 3012-X-302
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2007
• Last updated: June 16, 2011
• Start date: April 2007

Study information

• Verified date: June 2011
• Source: NicOx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1020
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Naproxcinod 375 mg bid
Naproxcinod 375 mg bid
• Naproxcinod 750 mg bid
Naproxcinod 750 mg bid
• Naproxen 500 mg bid
Naproxen 500 mg bid
• placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NicOx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		13 weeks	No
Secondary	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		52 weeks	No
Secondary	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		52 weeks	No
Secondary	To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach		52 weeks	No
Secondary	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)		52 weeks	No
Secondary	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)		53 weeks	Yes