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NCT00541489 Clinical Trial

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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00541489
Other study ID # HCT3012-X-303
Secondary ID
Status Completed
Phase Phase 3
First received October 8, 2007
Last updated February 19, 2009
Start date June 2007

Study information
Verified date February 2009
Source NicOx
Contact n/a
Is FDA regulated No
Health authority
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 randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Naproxcinod
750 mg, bid
• Naproxen
500 mg, bid
• Placebo
bid

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NicOx

Countries where clinical trial is conducted

United States,  Canada, 

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 hip
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