Official Title: “A 16-Week, Phase 1, Multicenter, Double-Blind, Randomized, Naproxen and Ibuprofen-Controlled, Parallel-Group Pharmacological Study, to Assess the Effect of Naproxcinod (375mg and750mg, Bid) Compared to Doses of Naproxen (250mg and 500mg, Bid) and to Ibuprofen (600mg, Tid) on Arterial Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Osteoarthritis Patients With Controlled Essential Hypertension.”

To assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in patients with osteoarthritis and controlled essential hypertension

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

This is a 16-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod, naproxen, and ibuprofen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to naproxcinod 375mg, naproxcinod 750mg, naproxen 250mg, naproxen 500mg, or ibuprofen 600mg in a 1:1:1:1:1 ratio.

Intervention(s) in this Clinical Trial

• Drug: naproxcinod, naproxen, ibuprofen
  • naproxcinod: 375mg, 750mg, naproxen: 250mg, 500mg, ibuprofen: 600mg

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: naproxcinod
  • 375mg, 750mg bid
• Active Comparator: naproxen
  • 250mg, 500mg bid
• Active Comparator: ibuprofen
  • 600mg tid

Primary Measures

• To characterize the 24-hour arterial blood pressure profile of naproxcinod, compared to naproxen as measured by ABPM, through assessing the mean change from baseline in patients with OA and controlled essential hypertension.
  • Time Frame: 15 weeks
    Safety Issue?: No

Secondary Measures

• To characterize the 24-hour arterial blood pressure profile of naproxcinod compared to ibuprofen as measured by ABPM, through assessing the mean change from baseline in patients with osteoarthritis and controlled essential hypertension.
  • Time Frame: 15 weeks
    Safety Issue?: No
• To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen.
  • Time Frame: 15 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Men/Women, 40 or older, diagnosed with hip or knee osteoarthritis.
• Hypertensive Patient with treated and controlled essential hypertension.
• Must receive at least one antihypertensive treatment from the following drug classes:
• Diuretic, Angiotensin-Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blockers (ARB) or Beta-Blocker (BB).
• Must be current chronic user of NSAIDS or acetaminophen.
• Must discontinue all analgesic therapy at Screening.

Exclusion Criteria:

• More than two different classes of antihypertensive drugs.
• Uncontrolled diabetes.
• Hepatic or renal impairment.
• A history of alcohol/drug abuse.
• Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding.
• History of congestive heart failure.
• Clinically relevant abnormal ECG.
• Current or history of a medical disease that could interfere with the study objectives or put the patient's safety at risk.
• Current or expected use of anticoagulants.
• Participation within 30 days prior to pre-screening in another investigational study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: NicOx

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00662896

Study ID Number: HCT 3012-X-112

ClinicalTrials.gov Identifier: NCT00662896

Health Authority: United States: Food and Drug Administration

Nicox web-site