To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension

Phase 1

Completed

• Conditions: Osteoarthritis; Hypertension
• Interventions: Drug: naproxcinod 375 mg bid; Drug: naproxen 250 mg bid; Drug: ibuprofen 600 mg tid; Drug: naproxcinod 750 mg bid; Drug: naproxen 500 mg bid

• Registration Number: NCT00662896
• Lead Sponsor: NicOx

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-21
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
naproxcinod 375 mg bid	naproxcinod 375 mg bid	-
naproxen 250 mg bid	naproxen 250 mg bid	-
ibuprofen 600 mg tid	ibuprofen 600 mg tid	-
naproxcinod 750 mg bid	naproxcinod 750 mg bid	-
naproxen 500 mg bid	naproxen 500 mg bid	-

Primary Outcome Measures

Name	Time	Method
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.	15 weeks

Secondary Outcome Measures

Name	Time	Method
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.	15 weeks
To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen.	15 weeks