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History of Changes for Study: NCT00542555
Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
Latest version (submitted June 16, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 10, 2007 None (earliest Version on record)
2 June 5, 2008 Study Status
3 October 23, 2008 Study Status
4 June 16, 2011 Arms and Interventions, Study Status, Sponsor/Collaborators and Study Identification
Comparison Format:

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Study NCT00542555
Submitted Date:  October 10, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: HCT3012-X-301/301E
Brief Title: Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2007
Overall Status: Completed
Study Start: December 2005
Primary Completion:
Study Completion:
First Submitted: October 10, 2007
First Submitted that
Met QC Criteria:
October 10, 2007
First Posted: October 11, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 10, 2007
Last Update Posted: October 11, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: NicOx
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Open or close this module Conditions
Conditions: Osteoarthritis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 918 [Actual]
Open or close this module Arms and Interventions
Intervention Details:
Drug: Placebo
Drug: Naproxcinod
Drug: Naproxen
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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 ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
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Links:
Available IPD/Information:

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