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

Primary Purpose

Osteoarthritis, Hypertension

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
naproxcinod 375 mg bid
naproxcinod 750 mg bid
naproxen 250 mg bid
naproxen 500 mg bid
ibuprofen 600 mg tid
Sponsored by
NicOx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Active Comparator

Arm Label

naproxcinod 375 mg bid

naproxen 250 mg bid

ibuprofen 600 mg tid

naproxcinod 750 mg bid

naproxen 500 mg bid

Arm Description

Outcomes

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.

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.
To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen.

Full Information

First Posted
April 16, 2008
Last Updated
June 16, 2011
Sponsor
NicOx
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1. Study Identification

Unique Protocol Identification Number
NCT00662896
Brief Title
To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension
Acronym
HCT3012-X-112
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
NicOx

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
naproxcinod 375 mg bid
Arm Type
Experimental
Arm Title
naproxen 250 mg bid
Arm Type
Active Comparator
Arm Title
ibuprofen 600 mg tid
Arm Type
Active Comparator
Arm Title
naproxcinod 750 mg bid
Arm Type
Experimental
Arm Title
naproxen 500 mg bid
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
naproxcinod 375 mg bid
Intervention Description
naproxcinod 375 mg bid
Intervention Type
Drug
Intervention Name(s)
naproxcinod 750 mg bid
Intervention Description
naproxcinod 750 mg bid
Intervention Type
Drug
Intervention Name(s)
naproxen 250 mg bid
Intervention Description
naproxen 250 mg bid
Intervention Type
Drug
Intervention Name(s)
naproxen 500 mg bid
Intervention Description
naproxen 500 mg bid
Intervention Type
Drug
Intervention Name(s)
ibuprofen 600 mg tid
Intervention Description
ibuprofen 600 mg tid
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen.
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
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Huntsville
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Alabama
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United States
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Sierra Vista
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Arizona
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Carmichael
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United States
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Fair Oaks
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Long Beach
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Pico Rivera
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Upland
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Denver
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Colorado
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Farmington
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Milford
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Washington
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Clearwater
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DeLand
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Fort Myers
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Gainesville
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Jupiter
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Kissimmee
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Miami
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Ormond Beach
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Pembroke Pines
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West Palm Beach
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Atlanta
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Georgia
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Decatur
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Marietta
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Georgia
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Arlington Heights
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Illinois
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Peoria
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Illinois
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Elizabethtown
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Kentucky
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Erlanger
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Kentucky
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Metairie
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Louisiana
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Shreveport
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Louisiana
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Auburn
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Maine
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Baltimore
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Towson
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Florissant
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Missoula
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Grand Island
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Nebraska
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Henderson
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Nevada
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Albuquerque
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New Mexico
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Rochester
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New York
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Charlotte
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North Carolina
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Concord
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Hickory
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North Carolina
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Lenoir
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Cincinnati
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Ohio
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Oklahoma City
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Oklahoma
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Havertown
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Tipton
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Charleston
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South Carolina
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Kingsport
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Tennessee
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New Tazewell
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Dallas
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Irving
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Longview
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San Antonio
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Salt Lake City
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Utah
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Madison
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Wisconsin
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nicox.com
Description
Nicox web-site

Learn more about this trial

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

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