OsteoarthritisPhase 3NCT00542555
Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
A Phase 3 study testing Naproxcinod 375 mg, Naproxen and Naproxcinod 750 mg in people with Osteoarthritis, run by NicOx.
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
- What is being tested?
- Naproxcinod 375 mg, Naproxen and Naproxcinod 750 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 918 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Sep 2007
- 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 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 anticoagulant
- A history of alcohol or drug abuse
- Candidates for imminent joint replacement
- Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
- Current medical disease that could confound or interfere with the evaluation of efficacy
- Participation within 30 days prior to screening in another investigational study
About this study
Official title: 301: A Phase 3 Study of the Analgesic Efficacy and Safety of HCT 3012: A Parallel, Randomized, Double Blind, 13 Week Placebo and Naproxen Controlled, Multicenter Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Patients With Osteoarthritis of the Knee, Followed by Its Extension (301E): A Parallel, Randomized, Open-Label, Multicenter, 52-Week Follow-up Safety Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Subjects With Osteoarthritis of the Knee
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 double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.
- Conditions
- Osteoarthritis
- Being tested
- Placebo, Naproxcinod 375 mg, Naproxen, Naproxcinod 750 mg
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.
Naproxcinod 375 mgDrug
NaproxenDrug
Naproxcinod 750 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo bid | Placebo comparator | At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study. Receives: Drug: Placebo |
| Naproxcinod 375 mg bid | Experimental | Not described Receives: Drug: Naproxcinod 375 mg |
| Naproxen 500 mg bid | Active comparator | Not described Receives: Drug: Naproxen |
| Naproxcinod 750 mg bid | Experimental | Not described Receives: Drug: Naproxcinod 750 mg |
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 knee at 13 weeks and to collect long term safety data
Measured: 13 weeks / long term
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startDec 2005
- Study completionSep 2007
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
- 918 participants (actual)
Sponsor and investigators
- Lead sponsor
- NicOx
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542555
- Sponsor's protocol ID
- HCT3012-X-301/301E
- Status last verified
- Jun 2011
- First submitted
- 10 Oct 2007
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schnitzer TJ, Kivitz A, Frayssinet H, Duquesroix B. Efficacy and safety of naproxcinod in the treatment of patients with osteoarthritis of the knee: a 13-week prospective, randomized, multicenter study. Osteoarthritis Cartilage. 2010 May;18(5):629-39. doi: 10.1016/j.joca.2009.12.013. Epub 2010 Feb 16.
PubMed 20202489
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
- 301: A Phase 3 Study of the Analgesic Efficacy and Safety of HCT 3012: A Parallel, Randomized, Double Blind, 13 Week Placebo and Naproxen Controlled, Multicenter Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Patients With Osteoarthritis of the Knee, Followed by Its Extension (301E): A Parallel, Randomized, Open-Label, Multicenter, 52-Week Follow-up Safety Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Subjects With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00542555
- Acronym / sponsor ID
- HCT3012-X-301/301E
- Conditions
- Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 918 participants (actual)
- Lead sponsor
- NicOxIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Sep 2007 (actual)
- First posted
- 11 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 double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo bid | Placebo comparator | Drug: PlaceboAt 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study. |
| Naproxcinod 375 mg bid | Experimental | Drug: Naproxcinod 375 mg |
| Naproxen 500 mg bid | Active comparator | Drug: Naproxen |
| Naproxcinod 750 mg bid | Experimental | Drug: Naproxcinod 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 knee
- Must be a current chronic user of NSAIDS or acetaminophen
- Must discontinue all analgesic therapy at screening
Key exclusion criteria (8 listed)
- Uncontrolled hypertension or diabetes
- Hepatic or renal impairment
- Current or expected use of anticoagulant
- A history of alcohol or drug abuse
- Candidates for imminent joint replacement
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 |
|---|---|---|
| PlaceboAt 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study. | Drug | Placebo bid |
| Naproxcinod 375 mg | Drug | Naproxcinod 375 mg bid |
| Naproxen | Drug | Naproxen 500 mg bid |
| Naproxcinod 750 mg | Drug | Naproxcinod 750 mg bid |
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 knee at 13 weeks and to collect long term safety data
Time frame: 13 weeks / long term
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.
- Derived from this study: PubMed 20202489Schnitzer TJ, Kivitz A, Frayssinet H, Duquesroix B. Efficacy and safety of naproxcinod in the treatment of patients with osteoarthritis of the knee: a 13-week prospective, randomized, multicenter study. Osteoarthritis Cartilage. 2010 May;18(5):629-39. doi: 10.1016/j.joca.2009.12.013. Epub 2010 Feb 16.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naproxcinod 375 mg, Naproxen and Naproxcinod 750 mg in people with Osteoarthritis, run by NicOx.
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 8 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.
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 knee at 13 weeks and to collect long term safety data (time frame: 13 weeks / long term). 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 NCT00542555, 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 17 Jun 2011.