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Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by:
NicOx
ClinicalTrials.gov Identifier:
NCT00542555
First received: October 10, 2007
Last updated: June 16, 2011
Last verified: June 2011
History of Changes
  Purpose

To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.


Condition Intervention Phase
Osteoarthritis
 Drug: Placebo
Drug: Naproxcinod 375 mg
Drug: Naproxen
Drug: Naproxcinod 750 mg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by NicOx:

Primary Outcome Measures:
  • 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 ]

Enrollment: 918
Study Start Date: December 2005
Study Completion Date: September 2007
Arms Assigned Interventions
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.
 Drug: Placebo
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.
Experimental: Naproxcinod 375 mg bid Drug: Naproxcinod 375 mg
Active Comparator: Naproxen 500 mg bid Drug: Naproxen
Experimental: Naproxcinod 750 mg bid Drug: Naproxcinod 750 mg

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by NicOx

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Brigitte Duquesroix, Senior Director Clinical Research, NicOx
ClinicalTrials.gov Identifier: NCT00542555     History of Changes
Other Study ID Numbers: HCT3012-X-301/301E
Study First Received: October 10, 2007
Last Updated: June 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics
Naproxen
Naproxen-n-butyl nitrate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nitric Oxide Donors
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013