- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00542555
Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
June 16, 2011 updated by: NicOx
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
918
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo bid
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.
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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.
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Experimental: Naproxcinod 375 mg bid
|
|
Active Comparator: Naproxen 500 mg bid
|
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Experimental: Naproxcinod 750 mg bid
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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13 weeks / long term
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
October 10, 2007
First Submitted That Met QC Criteria
October 10, 2007
First Posted (Estimate)
October 11, 2007
Study Record Updates
Last Update Posted (Estimate)
June 17, 2011
Last Update Submitted That Met QC Criteria
June 16, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Gout Suppressants
- Nitric Oxide Donors
- Naproxen
- Naproxen-n-butyl nitrate
Other Study ID Numbers
- HCT3012-X-301/301E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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