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OsteoarthritisPhase 1HCT3012-X-112NCT00662896

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

A Phase 1 study testing naproxcinod 375 mg bid, naproxcinod 750 mg bid and naproxen 250 mg bid in people with Osteoarthritis and Hypertension, run by NicOx at 57 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis, Hypertension
What is being tested?
naproxcinod 375 mg bid, naproxcinod 750 mg bid and naproxen 250 mg bid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
57 sitesUnited States
Study dates
Mar 2008to Dec 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

United States57 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Arlington Heights, Illinois

  • Study site

    Atlanta, Georgia

  • Study site

    Auburn, Maine

  • Study site

    Baltimore, Maryland

  • Study site

    Birmingham, Alabama

  • Study site

    Carmichael, California

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Concord, North Carolina

  • Study site

    Dallas, Texas

  • Study site

    Decatur, Georgia

  • Study site

    DeLand, Florida

  • Study site

    Denver, Colorado

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Erlanger, Kentucky

  • Study site

    Fair Oaks, California

  • Study site

    Farmington, Connecticut

  • Study site

    Florissant, Missouri

  • Study site

    Fort Myers, Florida

  • Study site

    Gainesville, Florida

  • Study site

    Grand Island, Nebraska

  • Study site

    Havertown, Pennsylvania

  • Study site

    Henderson, Nevada

  • Study site

    Hickory, North Carolina

  • Study site

    Huntsville, Alabama

  • Study site

    Irving, Texas

  • Study site

    Jupiter, Florida

  • Study site

    Kingsport, Tennessee

  • Study site

    Kissimmee, Florida

  • Study site

    Lenoir, North Carolina

  • Study site

    Long Beach, California

  • Study site

    Longview, Texas

  • Study site

    Madison, Wisconsin

  • Study site

    Marietta, Georgia

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Milford, Connecticut

  • Study site

    Missoula, Montana

  • Study site

    New Tazewell, Tennessee

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Ormond Beach, Florida

  • Study site

    Pembroke Pines, Florida

  • Study site

    Peoria, Illinois

  • Study site

    Pico Rivera, California

  • Study site

    Rochester, New York

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Shreveport, Louisiana

  • Study site

    Sierra Vista, Arizona

  • Study site

    Tipton, Pennsylvania

  • Study site

    Towson, Maryland

  • Study site

    Upland, California

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Palm Beach, Florida

Other trials in United States

About this 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.

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

Read the 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.

Being tested
naproxcinod 375 mg bid, naproxcinod 750 mg bid, naproxen 250 mg bid, naproxen 500 mg bid, ibuprofen 600 mg tid
Medical subject headings
Osteoarthritis, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • naproxcinod 375 mg bidDrug

    naproxcinod 375 mg bid

  • naproxcinod 750 mg bidDrug

    naproxcinod 750 mg bid

  • naproxen 250 mg bidDrug

    naproxen 250 mg bid

  • naproxen 500 mg bidDrug

    naproxen 500 mg bid

  • ibuprofen 600 mg tidDrug

    ibuprofen 600 mg tid

Study groups in NCT00662896
Study groupRoleWhat they receive
naproxcinod 375 mg bidExperimentalNot described
Receives: Drug: naproxcinod 375 mg bid
naproxen 250 mg bidActive comparatorNot described
Receives: Drug: naproxen 250 mg bid
ibuprofen 600 mg tidActive comparatorNot described
Receives: Drug: ibuprofen 600 mg tid
naproxcinod 750 mg bidExperimentalNot described
Receives: Drug: naproxcinod 750 mg bid
naproxen 500 mg bidActive comparatorNot described
Receives: Drug: naproxen 500 mg bid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 15 weeks

Secondary outcomes (2)

  1. 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.

    Measured: 15 weeks

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

    Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionSep 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00662896
Sponsor's protocol ID
HCT 3012-X-112
Acronym
HCT3012-X-112
Status last verified
Jun 2011
First submitted
16 Apr 2008
Last updated
17 Jun 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing naproxcinod 375 mg bid, naproxcinod 750 mg bid and naproxen 250 mg bid in people with Osteoarthritis and Hypertension, run by NicOx at 57 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00662896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2011.

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