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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Naproxcinod 375 mg bid
Naproxcinod 750 mg bid
Naproxen 500 mg bid
placebo
Sponsored by
NicOx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Arthritis, Degenerative

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

naproxcinod 375 mg bid

naproxcinod 750 mg bid

naproxen 500 mg bid

placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach
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)
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)

Full Information

First Posted
July 17, 2007
Last Updated
June 16, 2011
Sponsor
NicOx
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1. Study Identification

Unique Protocol Identification Number
NCT00504127
Brief Title
Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NicOx

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Arthritis, Degenerative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1020 (Actual)

8. Arms, Groups, and Interventions

Arm Title
naproxcinod 375 mg bid
Arm Type
Experimental
Arm Title
naproxcinod 750 mg bid
Arm Type
Experimental
Arm Title
naproxen 500 mg bid
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naproxcinod 375 mg bid
Intervention Description
Naproxcinod 375 mg bid
Intervention Type
Drug
Intervention Name(s)
Naproxcinod 750 mg bid
Intervention Description
Naproxcinod 750 mg bid
Intervention Type
Drug
Intervention Name(s)
Naproxen 500 mg bid
Intervention Description
Naproxen 500 mg bid
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach
Time Frame
52 weeks
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
City
Chandler
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Arizona
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United States
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Tempe
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Tucson
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Little Rock
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Anaheim
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Encino
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Foothill Ranch
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Orange
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Rancho Mirage
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Riverside
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Denver
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Waterbury
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Boca Raton
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Brooksville
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Deland
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Jacksonville
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Largo
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Ocala
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Pinellas Park
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St. Petersburg
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Tampa
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Athens
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Atlanta
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Marietta
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Chicago
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Rockford
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Prairie Village
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Wichita
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Erlanger
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Louisville
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Baton Rouge
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Owings Mills
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Edina
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Florissant
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St. Louis
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Rochester
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Charlotte
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Concord
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Raleigh
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Salisbury
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Winston-Salem
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Beachwood
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Columbus
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Marion
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Clinton
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Altoona
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Bensalem
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Duncansville
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Philadelphia
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West Reading
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Anderson
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Clinton
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Goose Creek
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Greer
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Mt Pleasant
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Cordova
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Jackson
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Kingsport
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Memphis
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Dallas
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Garland
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Houston
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Nederland
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San Antonio
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Salt Lake City
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Utah
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Norfolk
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Virginia
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Roanoke
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Virginia
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Virginia Beach
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Virginia
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United States
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Lakewood
State/Province
Washington
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United States

12. IPD Sharing Statement

Learn more about this trial

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

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