To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension (HCT3012-X-112)

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 Overview

• Status: Completed
• Conditions: Hypertension; Osteoarthritis
• Intervention / Treatment: Drug: naproxen 500 mg bid; Drug: naproxcinod 375 mg bid; Drug: naproxen 250 mg bid; Drug: ibuprofen 600 mg tid; Drug: naproxcinod 750 mg bid

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
    • Huntsville, Alabama, United States
  • Arizona
    • Sierra Vista, Arizona, United States
  • California
    • Carmichael, California, United States
    • Fair Oaks, California, United States
    • Long Beach, California, United States
    • Pico Rivera, California, United States
    • Upland, California, United States
  • Colorado
    • Denver, Colorado, United States
  • Connecticut
    • Farmington, Connecticut, United States
    • Milford, Connecticut, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Clearwater, Florida, United States
    • DeLand, Florida, United States
    • Fort Myers, Florida, United States
    • Gainesville, Florida, United States
    • Jupiter, Florida, United States
    • Kissimmee, Florida, United States
    • Miami, Florida, United States
    • Ormond Beach, Florida, United States
    • Pembroke Pines, Florida, United States
    • West Palm Beach, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
    • Decatur, Georgia, United States
    • Marietta, Georgia, United States
  • Illinois
    • Arlington Heights, Illinois, United States
    • Peoria, Illinois, United States
  • Kentucky
    • Elizabethtown, Kentucky, United States
    • Erlanger, Kentucky, United States
  • Louisiana
    • Metairie, Louisiana, United States
    • Shreveport, Louisiana, United States
  • Maine
    • Auburn, Maine, United States
  • Maryland
    • Baltimore, Maryland, United States
    • Towson, Maryland, United States
  • Missouri
    • Florissant, Missouri, United States
  • Montana
    • Missoula, Montana, United States
  • Nebraska
    • Grand Island, Nebraska, United States
  • Nevada
    • Henderson, Nevada, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • Rochester, New York, United States
  • North Carolina
    • Charlotte, North Carolina, United States
    • Concord, North Carolina, United States
    • Hickory, North Carolina, United States
    • Lenoir, North Carolina, United States
  • Ohio
    • Cincinnati, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Pennsylvania
    • Havertown, Pennsylvania, United States
    • Tipton, Pennsylvania, United States
  • South Carolina
    • Charleston, South Carolina, United States
  • Tennessee
    • Kingsport, Tennessee, United States
    • New Tazewell, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
    • Irving, Texas, United States
    • Longview, Texas, United States
    • San Antonio, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Wisconsin
    • Madison, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: naproxcinod 375 mg bid	Drug: naproxcinod 375 mg bid; naproxcinod 375 mg bid
Experimental: naproxcinod 750 mg bid	Drug: naproxcinod 750 mg bid; naproxcinod 750 mg bid
Active Comparator: naproxen 500 mg bid	Drug: naproxen 500 mg bid; naproxen 500 mg bid
Active Comparator: naproxen 250 mg bid	Drug: naproxen 250 mg bid; naproxen 250 mg bid
Active Comparator: ibuprofen 600 mg tid	Drug: ibuprofen 600 mg tid; ibuprofen 600 mg tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: NicOx

Publications and helpful links

Helpful Links

• Nicox web-site

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: April 16, 2008
• First Submitted That Met QC Criteria: April 16, 2008
• First Posted (Estimate): April 21, 2008

Study Record Updates

• Last Update Posted (Estimate): June 17, 2011
• Last Update Submitted That Met QC Criteria: June 16, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Hypertension; Osteoarthritis; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Nitric Oxide Donors; Ibuprofen; Naproxen; Naproxen-n-butyl nitrate
• Other Study ID Numbers: HCT 3012-X-112