OsteoarthritisPhase 3NCT00504127
Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
A Phase 3 study testing Naproxcinod 375 mg bid, Naproxcinod 750 mg bid and Naproxen 500 mg bid in people with Osteoarthritis, run by NicOx at 73 sites in United States.
Trial summary
To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication 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
- What is being tested?
- Naproxcinod 375 mg bid, Naproxcinod 750 mg bid and Naproxen 500 mg bid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,020 participants
- Where
- 73 sitesUnited States
- Study dates
- Apr 2007to Dec 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 Woman (40 or older) with a diagnosis of primary OA of the knee.
- 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 anti-coagulant
- Clinical relevant abnormal ECG
- A history of alcohol or drug abuse
- Candidates for imminent joint replacement
- Participation within 30 days prior to screening in another investigational study
Trial locations and contacts
73 sites in 1 country.
73 sites in 1 country
United States73 sites
Study site
Altoona, Pennsylvania
Study site
Anaheim, California
Study site
Anderson, South Carolina
Study site
Ann Arbor, Michigan
Study site
Asheville, North Carolina
Study site
Athens, Georgia
Study site
Atlanta, Georgia
Study site
Baton Rouge, Louisiana
Study site
Beachwood, Ohio
Study site
Bensalem, Pennsylvania
Study site
Boca Raton, Florida
Study site
Brooklyn Center, Minnesota
Study site
Brooksville, Florida
Study site
Chandler, Arizona
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Clinton, Oklahoma
Study site
Clinton, South Carolina
Study site
Columbus, Ohio
Study site
Concord, North Carolina
Study site
Cordova, Tennessee
Study site
Dallas, Texas
Study site
DeLand, Florida
Study site
Denver, Colorado
Study site
Duncansville, Pennsylvania
Study site
Edina, Minnesota
Study site
Encino, California
Study site
Erlanger, Kentucky
Study site
Florissant, Missouri
Study site
Foothill Ranch, California
Study site
Garland, Texas
Study site
Goose Creek, South Carolina
Study site
Greer, South Carolina
Study site
Houston, Texas
Study site
Jackson, Tennessee
Study site
Jacksonville, Florida
Study site
Kingsport, Tennessee
Study site
Lakewood, Washington
Study site
Largo, Florida
Study site
Little Rock, Arkansas
Study site
Louisville, Kentucky
Study site
Marietta, Georgia
Study site
Marion, Ohio
Study site
Memphis, Tennessee
Study site
Mt. Pleasant, South Carolina
Study site
Nederland, Texas
Study site
Norfolk, Virginia
Study site
Ocala, Florida
Study site
Orange, California
Study site
Owings Mills, Maryland
Study site
Philadelphia, Pennsylvania
Study site
Pinellas Park, Florida
Study site
Prairie Village, Kansas
Study site
Raleigh, North Carolina
Study site
Rancho Mirage, California
Study site
Riverside, California
Study site
Roanoke, Virginia
Study site
Rochester, New York
Study site
Rockford, Illinois
Study site
Salisbury, North Carolina
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Tampa, Florida
Study site
Tempe, Arizona
Study site
Tucson, Arizona
Study site
Virginia Beach, Virginia
Study site
Waterbury, Connecticut
Study site
Wellesley Hills, Massachusetts
Study site
West Reading, Pennsylvania
Study site
Wichita, Kansas
Study site
Winston-Salem, North Carolina
About this study
Official title: A Phase 3, 53 Weeks Study on Analgesic Efficacy and Safety of Naproxcinod (HCT 3012): 26-Week, Randomized, Parallel-Group, Double-Blind, Placebo (13 Weeks)- and Naproxen (26 Weeks)-Controlled, Multicenter Study of Naproxcinod (375 mg Bid and 750 mg Bid) With a 26-Week Naproxen-Controlled Safety Follow-up in Subjects With Osteoarthritis of the Knee, and a 1-week Post-treatment Safety Follow-up
To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis
Read the detailed description
This is a 53 week study consisting in a 26 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen. The first 26 weeks will be followed by a naproxen-controlled treatment period up to 52 weeks and a 1-week post-treatment safety follow-up.
- Conditions
- Osteoarthritis
- Being tested
- Naproxcinod 375 mg bid, Naproxcinod 750 mg bid, Naproxen 500 mg bid, placebo
- Keywords
- Arthritis, Degenerative
- Medical subject headings
- Osteoarthritis, Arthritis
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 500 mg bidDrug
Naproxen 500 mg bid
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| naproxcinod 375 mg bid | Experimental | Not described Receives: Drug: Naproxcinod 375 mg bid |
| naproxcinod 750 mg bid | Experimental | Not described Receives: Drug: Naproxcinod 750 mg bid |
| naproxen 500 mg bid | Active comparator | Not described Receives: Drug: Naproxen 500 mg bid |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To show that both doses of Naproxcinod (375 mg twice daily [bid] and 750 mg bid) were superior to placebo in relieving osteoarthritis (OA) signs and symptoms in subjects with OA of the knee at Week 13.
Measured: 13 weeks
Secondary outcomes (5)
To assess the efficacy of naproxcinod compared to naproxen 500 mg bid in relieving OA signs and symptoms in subjects with OA of the knee
Measured: 52 weeks
To evaluate the effect on blood pressure (BP) of both doses of naproxcinod, placebo, and naproxen 500 mg bid, as measured by the office BP monitoring in a population of OA subjects
Measured: 52 weeks
To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach
Measured: 52 weeks
To assess if there were any radiological changes at Week 52 in naproxcinod compared with naproxen subjects (target joint radiographs were taken at Screening and after 52 weeks of treatment, or if early termination occurred after Week 26)
Measured: 52 weeks
To compare the general safety and tolerability of both doses of naproxcinod versus naproxen 500 mg bid up to 52 weeks and with one Week post treatment follow up (Week 53)
Measured: 53 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startApr 2007
- Primary completionDec 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- NicOx
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504127
- Sponsor's protocol ID
- HCT 3012-X-302
- Status last verified
- Jun 2011
- First submitted
- 17 Jul 2007
- 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 Phase 3, 53 Weeks Study on Analgesic Efficacy and Safety of Naproxcinod (HCT 3012): 26-Week, Randomized, Parallel-Group, Double-Blind, Placebo (13 Weeks)- and Naproxen (26 Weeks)-Controlled, Multicenter Study of Naproxcinod (375 mg Bid and 750 mg Bid) With a 26-Week Naproxen-Controlled Safety Follow-up in Subjects With Osteoarthritis of the Knee, and a 1-week Post-treatment Safety Follow-up
- ClinicalTrials.gov ID
- NCT00504127
- Acronym / sponsor ID
- HCT 3012-X-302
- Conditions
- Osteoarthritis
- Keywords
- Arthritis, Degenerative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (actual)
- Lead sponsor
- NicOxIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- First posted
- 19 Jul 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 of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis
Detailed description
This is a 53 week study consisting in a 26 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen. The first 26 weeks will be followed by a naproxen-controlled treatment period up to 52 weeks and a 1-week post-treatment safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| naproxcinod 375 mg bid | Experimental | Drug: Naproxcinod 375 mg bid |
| naproxcinod 750 mg bid | Experimental | Drug: Naproxcinod 750 mg bid |
| naproxen 500 mg bid | Active comparator | Drug: Naproxen 500 mg bid |
| placebo | Placebo comparator | Drug: placebo |
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 Woman (40 or older) with a diagnosis of primary OA of the knee.
- Must be a current chronic user of NSAIDS or acetaminophen
- Must discontinue all analgesic therapy at Screening
Key exclusion criteria (7 listed)
- Uncontrolled Hypertension or Diabetes
- Hepatic or Renal Impairment
- Current or expected use of anti-coagulant
- Clinical 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 |
|---|---|---|
| Naproxcinod 375 mg bidNaproxcinod 375 mg bid | Drug | naproxcinod 375 mg bid |
| Naproxcinod 750 mg bidNaproxcinod 750 mg bid | Drug | naproxcinod 750 mg bid |
| Naproxen 500 mg bidNaproxen 500 mg bid | Drug | naproxen 500 mg bid |
| placeboplacebo | Drug | placebo |
Primary outcome
To show that both doses of Naproxcinod (375 mg twice daily [bid] and 750 mg bid) were superior to placebo in relieving osteoarthritis (OA) signs and symptoms in subjects with OA of the knee at Week 13.
Time frame: 13 weeks
5 secondary outcomes
To assess the efficacy of naproxcinod compared to naproxen 500 mg bid in relieving OA signs and symptoms in subjects with OA of the knee
Time frame: 52 weeks
To evaluate the effect on blood pressure (BP) of both doses of naproxcinod, placebo, and naproxen 500 mg bid, as measured by the office BP monitoring in a population of OA subjects
Time frame: 52 weeks
To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach
Time frame: 52 weeks
To assess if there were any radiological changes at Week 52 in naproxcinod compared with naproxen subjects (target joint radiographs were taken at Screening and after 52 weeks of treatment, or if early termination occurred after Week 26)
Time frame: 52 weeks
To compare the general safety and tolerability of both doses of naproxcinod versus naproxen 500 mg bid up to 52 weeks and with one Week post treatment follow up (Week 53)
Time frame: 53 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.
73 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naproxcinod 375 mg bid, Naproxcinod 750 mg bid and Naproxen 500 mg bid in people with Osteoarthritis, run by NicOx at 73 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 3 inclusion and 7 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 73 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. 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?
To show that both doses of Naproxcinod (375 mg twice daily [bid] and 750 mg bid) were superior to placebo in relieving osteoarthritis (OA) signs and symptoms in subjects with OA of the knee at Week 13. (time frame: 13 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.