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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00541489

Enrollment

800

Registered

2007-10-10

Start date

2007-06-30

Completion date

Unknown

Last updated

2009-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Osteoarthritis, Hip

Keywords

Osteoarthritis, Osteoarthritis, Hip

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.

Interventions

DRUGNaproxcinod

750 mg, bid

DRUGNaproxen

500 mg, bid

DRUGPlacebo

bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026