OsteoarthritisPhase 3NCT00541489
Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip
A Phase 3 study testing Naproxcinod and Naproxen in people with Osteoarthritis and Osteoarthritis, Hip, run by NicOx at 48 sites in 2 countries.
Trial summary
To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Hip
- What is being tested?
- Naproxcinod and Naproxen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 48 sitesin 2 countries
- Study dates
- Jun 2007to Sep 2008
- Phase
- Phase 3
- 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 and women (40 or older) with a diagnosis of primary OA of the hip
- Must be a current chronic user of NSAIDS or acetaminophen
- Must discontinue all analgesic therapy at Screening
Who cannot join
- Uncontrolled Hypertension or Diabetes
- Hepatic or renal impairment
- Current or expected use of anticoagulant
- Clinically relevant abnormal ECG
- A history of alcohol or drug abuse
- Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
Show all 9Show fewer
- Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy
- Candidates for imminent joint replacement
- Participation within 30 days prior to screening in another investigational study
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States36 sites
Study site
Anderson, South Carolina, 29621
Study site
Austin, Texas, 78705
Study site
Berlin, New Jersey, 08009
Study site
Bethany, Oklahoma, 73008
Study site
Chandler, Arizona, 85224
Study site
Cincinnati, Ohio, 45224
Study site
Cleveland, Ohio, 44122
Study site
Columbia, South Carolina, 29204
Study site
Coral Gables, Florida, 33134
Study site
Daytona Beach, Florida, 32117
Study site
DeLand, Florida, 32720
Study site
Dover, New Jersey, 07801
Study site
Duncansville, Pennsylvania, 16635
Study site
Fair Oaks, California, 95628
Study site
Fort Meyers, Florida, 33916
Study site
Franklin, Ohio, 45005
Study site
Jupiter, Florida, 33458
Study site
Kalamazoo, Michigan, 49009
Study site
Kingsport, Tennessee, 37660
Study site
Louisville, Kentucky, 40291
Study site
Mesa, Arizona, 85213
Study site
Mobile, Alabama, 36608
Study site
Montgomery, Alabama, 36106
Study site
Nederland, Texas, 77627
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Newport News, Virginia, 23606
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Northglenn, Colorado, 80234
Study site
Peabody, Massachusetts, 01960
Study site
Penndel, Pennsylvania, 19047
Study site
Phoenix, Arizona, 85016
Study site
Rochester, New York, 14609
Study site
Saginaw, Michigan, 48602
Study site
San Antonio, Texas, 78217
Study site
San Diego, California, 92120
Study site
Santa Barbara, California, 93111
Study site
Tuscaloosa, Alabama, 35406
Study site
Warwick, Rhode Island, 02886
Canada12 sites
Study site
Burnaby, British Columbia, V5G 1T4
Study site
Coquitlam, British Columbia, V3K 3P4
Study site
Corunna, Ontario, N0N 1G0
Study site
Kitchener, Ontario, N2M 5N6
Study site
Mississauga, Ontario, L4T 4J2
Study site
Newmarket, Ontario, L3Y 5G8
Study site
Québec, Quebec, G1V 3M7
Study site
Regina, Saskatchewan, S4P 3X1
Study site
Saskatoon, Saskatchewan, S7K 3H3
Study site
Toronto, Ontario, M9W 4L6
Study site
Trois-Rivières, Quebec, G8Z 1Y2
Study site
Vancouver, British Columbia, V5Z 1K3
About this study
Official title: A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the Hip
To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.
Read the detailed description
This is a 13 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.
- Conditions
- Osteoarthritis, Osteoarthritis, Hip
- Being tested
- Naproxcinod, Naproxen, Placebo
- Keywords
- Osteoarthritis, Osteoarthritis, Hip
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxcinodDrug
750 mg, bid
NaproxenDrug
500 mg, bid
PlaceboDrug
bid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Active comparator | Naproxen 500 mg Receives: Drug: Naproxen |
| 3 | Experimental | Naproxcinod 750 mg Receives: Drug: Naproxcinod |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to show that Naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the hip
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startJun 2007
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NicOx
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541489
- Sponsor's protocol ID
- HCT3012-X-303
- Status last verified
- Feb 2009
- First submitted
- 8 Oct 2007
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baerwald C, Verdecchia P, Duquesroix B, Frayssinet H, Ferreira T. Efficacy, safety, and effects on blood pressure of naproxcinod 750 mg twice daily compared with placebo and naproxen 500 mg twice daily in patients with osteoarthritis of the hip: a randomized, double-blind, parallel-group, multicenter study. Arthritis Rheum. 2010 Dec;62(12):3635-44. doi: 10.1002/art.27694.
PubMed 20722026
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the Hip
- ClinicalTrials.gov ID
- NCT00541489
- Acronym / sponsor ID
- HCT3012-X-303
- Conditions
- Osteoarthritis, Osteoarthritis, Hip
- Keywords
- Osteoarthritis, Osteoarthritis, Hip
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- NicOxIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Sep 2008 (actual)
- First posted
- 10 Oct 2007 (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 study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.
Detailed description
This is a 13 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Active comparator | Drug: NaproxenNaproxen 500 mg |
| 3 | Experimental | Drug: NaproxcinodNaproxcinod 750 mg |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women (40 or older) with a diagnosis of primary OA of the hip
- Must be a current chronic user of NSAIDS or acetaminophen
- Must discontinue all analgesic therapy at Screening
Key exclusion criteria (9 listed)
- Uncontrolled Hypertension or Diabetes
- Hepatic or renal impairment
- Current or expected use of anticoagulant
- Clinically relevant abnormal ECG
- A history of alcohol or drug abuse
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 |
|---|---|---|
| Naproxcinod750 mg, bid | Drug | 3 |
| Naproxen500 mg, bid | Drug | 2 |
| Placebobid | Drug | 1 |
Primary outcome
The primary objective of this study is to show that Naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the hip
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 20 Feb 2009.
- Derived from this study: PubMed 20722026Baerwald C, Verdecchia P, Duquesroix B, Frayssinet H, Ferreira T. Efficacy, safety, and effects on blood pressure of naproxcinod 750 mg twice daily compared with placebo and naproxen 500 mg twice daily in patients with osteoarthritis of the hip: a randomized, double-blind, parallel-group, multicenter study. Arthritis Rheum. 2010 Dec;62(12):3635-44. doi: 10.1002/art.27694.
- Click here to learn more about this study - Efficacy and Safety Study of Naproxcinod in Subjects with Osteoarthritis of the HipLink provided by the sponsor.
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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.
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naproxcinod and Naproxen in people with Osteoarthritis and Osteoarthritis, Hip, run by NicOx at 48 sites in 2 countries.
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 3 inclusion and 9 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 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary objective of this study is to show that Naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the hip. 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 NCT00541489, which also lists 1 linked publication.
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 20 Feb 2009.