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

Primary Purpose

Osteoarthritis, Osteoarthritis, Hip

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Naproxcinod
Naproxen
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 Osteoarthritis, Osteoarthritis, Hip

Eligibility Criteria

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

Inclusion Criteria:

  • Men and women (40 or older) with a diagnosis of primary OA of the hip
  • 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
  • Clinically relevant abnormal ECG
  • A history of alcohol or drug abuse
  • Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
  • Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy
  • 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 Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

Naproxen 500 mg

Naproxcinod 750 mg

Outcomes

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 hip

Secondary Outcome Measures

Full Information

First Posted
October 8, 2007
Last Updated
February 19, 2009
Sponsor
NicOx
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1. Study Identification

Unique Protocol Identification Number
NCT00541489
Brief Title
Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip
Official Title
A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the Hip
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 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 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 randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Description
Naproxen 500 mg
Arm Title
3
Arm Type
Experimental
Arm Description
Naproxcinod 750 mg
Intervention Type
Drug
Intervention Name(s)
Naproxcinod
Intervention Description
750 mg, bid
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
500 mg, bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
bid
Primary Outcome Measure Information:
Title
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 hip

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women (40 or older) with a diagnosis of primary OA of the hip 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 Clinically relevant abnormal ECG A history of alcohol or drug abuse Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy Candidates for imminent joint replacement Participation within 30 days prior to screening in another investigational study
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93111
Country
United States
City
Northglenn
State/Province
Colorado
ZIP/Postal Code
80234
Country
United States
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
City
Dover
State/Province
New Jersey
ZIP/Postal Code
07801
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Penndel
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Nederland
State/Province
Texas
ZIP/Postal Code
77627
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 1T4
Country
Canada
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3P4
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1K3
Country
Canada
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N 1G0
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4T 4J2
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 3X1
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20722026
Citation
Baerwald C, Verdecchia P, Duquesroix B, Frayssinet H, Ferreira T. Efficacy, safety, and effects on blood pressure of naproxcinod 750 mg twice daily compared with placebo and naproxen 500 mg twice daily in patients with osteoarthritis of the hip: a randomized, double-blind, parallel-group, multicenter study. Arthritis Rheum. 2010 Dec;62(12):3635-44. doi: 10.1002/art.27694.
Results Reference
derived
Links:
URL
http://www.nicox.com
Description
Click here to learn more about this study - Efficacy and Safety Study of Naproxcinod in Subjects with Osteoarthritis of the Hip

Learn more about this trial

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

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