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

Sponsor:	NicOx
Information provided by:	NicOx
ClinicalTrials.gov Identifier:	NCT00662896

Purpose

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

Condition	Intervention	Phase
Osteoarthritis Hypertension	Drug: naproxcinod, naproxen, ibuprofen	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Osteoarthritis

Drug Information available for: Ibuprofen Naproxen Naproxen sodium Dexibuprofen AZD 3582

U.S. FDA Resources

Further study details as provided by NicOx:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen. [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	March 2008
Study Completion Date:	December 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
naproxcinod: Active Comparator 375mg, 750mg bid	Drug: naproxcinod, naproxen, ibuprofen naproxcinod: 375mg, 750mg, naproxen: 250mg, 500mg, ibuprofen: 600mg
naproxen: Active Comparator 250mg, 500mg bid	Drug: naproxcinod, naproxen, ibuprofen naproxcinod: 375mg, 750mg, naproxen: 250mg, 500mg, ibuprofen: 600mg
ibuprofen: Active Comparator 600mg tid	Drug: naproxcinod, naproxen, ibuprofen naproxcinod: 375mg, 750mg, naproxen: 250mg, 500mg, ibuprofen: 600mg

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662896

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Locations

United States, Alabama

Huntsville, Alabama, United States

Birmingham, Alabama, United States

Huntsville, Alabama, United States
United States, Arizona

Sierra Vista, Arizona, United States
United States, California

Carmichael, California, United States

Pico Rivera, California, United States

Fair Oaks, California, United States

Upland, California, United States

Long Beach, California, United States
United States, Colorado

Denver, Colorado, United States
United States, Connecticut

Milford, Connecticut, United States

Farmington, Connecticut, United States
United States, District of Columbia

Washington, District of Columbia, United States
United States, Florida

Clearwater, Florida, United States

Kissimmee, Florida, United States

DeLand, Florida, United States

Pembroke Pines, Florida, United States

Fort Myers, Florida, United States

Miami, Florida, United States

Ormond Beach, Florida, United States

Gainesville, Florida, United States

Jupiter, Florida, United States

West Palm Beach, Florida, United States

Miami, Florida, United States
United States, Georgia

Decatur, Georgia, United States

Atlanta, Georgia, United States

Marietta, Georgia, United States
United States, Illinois

Arlington Heights, Illinois, United States

Peoria, Illinois, United States
United States, Kentucky

Elizabethtown, Kentucky, United States

Erlanger, Kentucky, United States
United States, Louisiana

Shreveport, Louisiana, United States

Metairie, Louisiana, United States
United States, Maine

Auburn, Maine, United States
United States, Maryland

Baltimore, Maryland, United States

Towson, Maryland, United States
United States, Missouri

Florissant, Missouri, United States
United States, Montana

Missoula, Montana, United States
United States, Nebraska

Grand Island, Nebraska, United States
United States, Nevada

Henderson, Nevada, United States
United States, New Mexico

Albuquerque, New Mexico, United States

Albuquerque, New Mexico, United States
United States, New York

Rochester, New York, United States
United States, North Carolina

Charlotte, North Carolina, United States

Hickory, North Carolina, United States

Concord, North Carolina, United States

Lenoir, North Carolina, United States
United States, Ohio

Cincinnati, Ohio, United States
United States, Oklahoma

Oklahoma City, Oklahoma, United States
United States, Pennsylvania

Havertown, Pennsylvania, United States

Tipton, Pennsylvania, United States
United States, South Carolina

Charleston, South Carolina, United States
United States, Tennessee

New Tazewell, Tennessee, United States

Kingsport, Tennessee, United States
United States, Texas

Dallas, Texas, United States

San Antonio, Texas, United States

Dallas, Texas, United States

Irving, Texas, United States

Longview, Texas, United States
United States, Utah

Salt Lake City, Utah, United States
United States, Wisconsin

Madison, Wisconsin, United States

Sponsors and Collaborators

NicOx

More Information

Additional Information:

Nicox web-site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	NicOx. ( NicOx )
Study ID Numbers:	HCT 3012-X-112
Study First Received:	April 16, 2008
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00662896 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Physiological Effects of Drugs
Gout Suppressants
Nitric Oxide Donors
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics
Ibuprofen

Naproxen
Joint Diseases
Cyclooxygenase Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Rheumatic Diseases
Pharmacologic Actions
Analgesics, Non-Narcotic
Naproxen-n-butyl nitrate
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Hypertension

ClinicalTrials.gov processed this record on November 25, 2009