OsteoarthritisPhase 1HCT3012-X-111NCT00662610
A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure
A Phase 1 study testing naproxcinod 375 mg -750 mg -1125 mg bid and naproxen 250 mg - 500mg -750 mg bid in people with Osteoarthritis and Hypertension, run by NicOx at 29 sites in United States.
Trial summary
To assess the effect of naproxcinod vs. naproxen on arterial blood pressure 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 -750 mg -1125 mg bid and naproxen 250 mg - 500mg -750 mg bid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 29 sitesUnited States
- Study dates
- Mar 2008to Nov 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 Blocker (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.
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- Clinically relevant abnormal ECG.
- Current or expected use of anticoagulants.
- Current or history of any medical disease that could interfere with the study objectives or put the patient's safety at risk.
- Participation within 30 days prior to pre-screening in another investigational study.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Study site
Austin, Texas
Study site
Beverly Hills, California
Study site
Billings, Montana
Study site
Binghamton, New York
Study site
Boise, Idaho
Study site
Boynton Beach, Florida
Study site
Buena Park, California
Study site
Chicago, Illinois
Study site
Clarksville, Tennessee
Study site
Cleveland, Ohio
Study site
Colorado Springs, Colorado
Study site
Dallas, Texas
Study site
Duncansville, Pennsylvania
Study site
Edison, New Jersey
Study site
Evansville, Indiana
Study site
Houston, Texas
Study site
Johnson City, New York
Study site
Las Vegas, Nevada
Study site
Louisville, Kentucky
Study site
Mobile, Alabama
Study site
New Orleans, Louisiana
Study site
Newburgh, Indiana
Study site
Norfolk, Virginia
Study site
Philadelphia, Pennsylvania
Study site
Stockbridge, Georgia
Study site
Tempe, Arizona
Study site
Terre Haute, Indiana
Study site
Tucson, Arizona
Study site
Winston-Salem, North Carolina
About this study
Official title: A 12-Week, Phase 1, Multicenter, Double-Blind, Randomized, Dose Ranging, Forced Titration, Naproxen-Controlled, Parallel-Group, Pharmacodynamic Study, to Assess the Effects Different Doses of Naproxcinod and Naproxen 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 on arterial blood pressure patients with osteoarthritis and controlled essential hypertension
Read the detailed description
This is a 12-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod and naproxen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to different naproxcinod or naproxen doses in a 1:1 ratio.
- Conditions
- Osteoarthritis, Hypertension
- Being tested
- naproxcinod 375 mg -750 mg -1125 mg bid, naproxen 250 mg - 500mg -750 mg bid
- 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 -750 mg -1125 mg bidDrug
naproxcinod 375 mg -750 mg -1125 mg bid
naproxen 250 mg - 500mg -750 mg bidDrug
naproxen 250 mg - 500mg -750 mg bid
| Study group | Role | What they receive |
|---|---|---|
| naproxcinod 375 mg - 750 mg -1125 mg bid | Experimental | dose escalating Receives: Drug: naproxcinod 375 mg -750 mg -1125 mg bid |
| naproxen 250 mg -500 mg -750 mg bid | Active comparator | dose escalating Receives: Drug: naproxen 250 mg - 500mg -750 mg bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the 24-hour arterial blood pressure profile of different doses of naproxcinod, as measured by ABPM after each treatment period, compared to different doses of naproxen after three 3-week forced titration.
Measured: 11 weeks
Secondary outcomes (1)
To evaluate the general safety and tolerability as well as the PK/PD profile of different doses of naproxcinod compared to different doses of naproxen.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NicOx
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662610
- Sponsor's protocol ID
- HCT3012-X-111
- Acronym
- HCT3012-X-111
- Status last verified
- Jun 2011
- First submitted
- 16 Apr 2008
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Phase 1, Multicenter, Double-Blind, Randomized, Dose Ranging, Forced Titration, Naproxen-Controlled, Parallel-Group, Pharmacodynamic Study, to Assess the Effects Different Doses of Naproxcinod and Naproxen on Arterial Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Osteoarthritis Patients With Controlled Essential Hypertension
- ClinicalTrials.gov ID
- NCT00662610
- Acronym / sponsor ID
- HCT3012-X-111 / HCT3012-X-111
- Conditions
- Osteoarthritis, Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- NicOxIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effect of naproxcinod vs. naproxen on arterial blood pressure patients with osteoarthritis and controlled essential hypertension
Detailed description
This is a 12-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod and naproxen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to different naproxcinod or naproxen doses in a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| naproxcinod 375 mg - 750 mg -1125 mg bid | Experimental | Drug: naproxcinod 375 mg -750 mg -1125 mg biddose escalating |
| naproxen 250 mg -500 mg -750 mg bid | Active comparator | Drug: naproxen 250 mg - 500mg -750 mg biddose escalating |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 Blocker (ARB) or Beta-Blocker (BB).
- Must be current chronic user of NSAIDS or acetaminophen.
- Must discontinue all analgesic therapy at Screening.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naproxcinod 375 mg -750 mg -1125 mg bidnaproxcinod 375 mg -750 mg -1125 mg bid | Drug | naproxcinod 375 mg - 750 mg -1125 mg bid |
| naproxen 250 mg - 500mg -750 mg bidnaproxen 250 mg - 500mg -750 mg bid | Drug | naproxen 250 mg -500 mg -750 mg bid |
Primary outcome
To characterize the 24-hour arterial blood pressure profile of different doses of naproxcinod, as measured by ABPM after each treatment period, compared to different doses of naproxen after three 3-week forced titration.
Time frame: 11 weeks
1 secondary outcome
To evaluate the general safety and tolerability as well as the PK/PD profile of different doses of naproxcinod compared to different doses of naproxen.
Time frame: 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing naproxcinod 375 mg -750 mg -1125 mg bid and naproxen 250 mg - 500mg -750 mg bid in people with Osteoarthritis and Hypertension, run by NicOx at 29 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 29 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 different doses of naproxcinod, as measured by ABPM after each treatment period, compared to different doses of naproxen after three 3-week forced titration. (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.