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

Osteoarthritis Clinical Trial

Official title:

301: A Phase 3 Study of the Analgesic Efficacy and Safety of HCT 3012: A Parallel, Randomized, Double Blind, 13 Week Placebo and Naproxen Controlled, Multicenter Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Patients With Osteoarthritis of the Knee, Followed by Its Extension (301E): A Parallel, Randomized, Open-Label, Multicenter, 52-Week Follow-up Safety Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Subjects With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542555
• Other study ID #: HCT3012-X-301/301E
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2007
• Last updated: June 16, 2011
• Start date: December 2005
• Est. completion date: September 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 the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.

Description:

This is a 13-week double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 918
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Men and women (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 anticoagulant

• A history of alcohol or drug abuse

• Candidates for imminent joint replacement

• Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months

• Current medical disease that could confound or interfere with the evaluation of efficacy

• 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:
• Placebo
At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.
• Naproxcinod 375 mg

• Naproxen

• Naproxcinod 750 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NicOx

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 knee at 13 weeks and to collect long term safety data		13 weeks / long term