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Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Diclofenac Sodium Gel
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Knee osteoarthritis, degenerative joint disease, knee pain, joint pain, topical NSAID,, diclofenac sodium

Eligibility Criteria

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

Inclusion Criteria:

  • Osteoarthritis of the knee

Exclusion Criteria:

  • Other rheumatic disease, such as rheumatoid arthritis
  • Active gastrointestinal ulcer during the last year
  • Known allergy to analgesic drugs
  • Other protocol defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Coastal Clinical Research Inc
  • River Region Research, LLC
  • East Valley Family Physicians
  • HOPE Research Institute
  • Heartland Research Associates LLC
  • Lovelace Scientific Research, Inc.
  • MED Investigations
  • MED Investigations, Inc.
  • Universal BioPharma Research, Inc.
  • Santa Barbara Clinical Research, Inc
  • Pacific Arthritis Center Medical Group
  • Clinical Research Consultants, LLC
  • Seidman Clinical Trials
  • Florida Medical Research Institute
  • South Florida Clinical Research Center
  • Health Awareness, Inc.
  • Suncoast Internal Medicine Consultants
  • AppleMed Research, Inc.
  • Suncoast Clinical Research, Inc.
  • Sunshine Research Center, LLC
  • Peninsula Research, Inc.
  • University Clinical Research, Inc.
  • Andres Patron DO PA
  • Radiant Research - St Petersburg
  • Sunrise Medical Research
  • Coastal Medical Research
  • Radiant Research
  • Intermountain Orthopaedics
  • Medical Specialists Clinical Research Center
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Best Clinical Trial, LLC
  • Peter A. Holt, MD
  • The Center for Rheumatology and Bone Research
  • Phase III Clinical Research
  • Professional Clinical Research, Inc
  • Twin Cities Clinical Research
  • The Center for Pharmaceutical Research
  • St. Louis Center for Clinical Research
  • Internal Medical Associates
  • South Jersey Medical Associates, PA
  • North Carolina Arthritis & Allergy Care Center
  • Rapid Medical Research, Inc
  • Radiant Research
  • Radiant Research, Inc. - Akron
  • Clinical Research Source, Inc
  • Neshaminy Medical, PC
  • Westminster Family Medicine
  • Feasterville Family Health Care Center
  • Southeastern Pennsylvania Medical Institute
  • Radiant Research
  • Omega Medical Research
  • Radiant Research - Anderson
  • Holston Medical Group
  • Amarillo Center for Clinical Research
  • Walter F. Chase, M.D., P.A.
  • Radiant Research Dallas North
  • Quality Research, Inc.
  • Radiant Research - San Antonio
  • Texas Research Center, LLP
  • Health Research of Hampton Roads, Inc.
  • Tidewater Integrated Medical Research
  • The Physicians Clinic of Spokane
  • Advanced Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

pain in the target knee (WOMAC pain index);
functional capacity in the target knee (WOMAC function index); and
global rating of benefit (100 mm Visual Analogue Scale, VAS).

Secondary Outcome Measures

Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
Low pain intensity in either knee; and
Low functional impairment in either knee.
Safety of Diclofenac Sodium Gel 1% assessed by:
monitoring adverse events; and
laboratory evaluations.

Full Information

First Posted
January 24, 2007
Last Updated
December 13, 2007
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00426621
Brief Title
Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis
Official Title
A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Knee osteoarthritis, degenerative joint disease, knee pain, joint pain, topical NSAID,, diclofenac sodium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Diclofenac Sodium Gel
Intervention Description
4 grams per knee, 4 times per day, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 grams per knee, 4 times per day, for 12 weeks
Primary Outcome Measure Information:
Title
pain in the target knee (WOMAC pain index);
Title
functional capacity in the target knee (WOMAC function index); and
Title
global rating of benefit (100 mm Visual Analogue Scale, VAS).
Secondary Outcome Measure Information:
Title
Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
Title
Low pain intensity in either knee; and
Title
Low functional impairment in either knee.
Title
Safety of Diclofenac Sodium Gel 1% assessed by:
Title
monitoring adverse events; and
Title
laboratory evaluations.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Osteoarthritis of the knee Exclusion Criteria: Other rheumatic disease, such as rheumatoid arthritis Active gastrointestinal ulcer during the last year Known allergy to analgesic drugs Other protocol defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Altman, MD
Organizational Affiliation
University of California, in Los Angeles, Division of Rheumatology, 310 206 7866
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coastal Clinical Research Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
33608
Country
United States
Facility Name
River Region Research, LLC
City
Tallassee
State/Province
Alabama
ZIP/Postal Code
36078
Country
United States
Facility Name
East Valley Family Physicians
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Heartland Research Associates LLC
City
Arkansas City
State/Province
Arkansas
ZIP/Postal Code
67005
Country
United States
Facility Name
Lovelace Scientific Research, Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
MED Investigations
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
MED Investigations, Inc.
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Universal BioPharma Research, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93703
Country
United States
Facility Name
Santa Barbara Clinical Research, Inc
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93108
Country
United States
Facility Name
Pacific Arthritis Center Medical Group
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Clinical Research Consultants, LLC
City
Stratford
State/Province
Connecticut
ZIP/Postal Code
06615
Country
United States
Facility Name
Seidman Clinical Trials
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Florida Medical Research Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
South Florida Clinical Research Center
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Suncoast Internal Medicine Consultants
City
Largo
State/Province
Florida
ZIP/Postal Code
33774
Country
United States
Facility Name
AppleMed Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Sunshine Research Center, LLC
City
Opa Locka
State/Province
Florida
ZIP/Postal Code
33056
Country
United States
Facility Name
Peninsula Research, Inc.
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Andres Patron DO PA
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Radiant Research - St Petersburg
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Sunrise Medical Research
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Coastal Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Radiant Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
Intermountain Orthopaedics
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Medical Specialists Clinical Research Center
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Best Clinical Trial, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Peter A. Holt, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Phase III Clinical Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Professional Clinical Research, Inc
City
Cadillac
State/Province
Michigan
ZIP/Postal Code
49601
Country
United States
Facility Name
Twin Cities Clinical Research
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Internal Medical Associates
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
South Jersey Medical Associates, PA
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
North Carolina Arthritis & Allergy Care Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Rapid Medical Research, Inc
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Radiant Research, Inc. - Akron
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
Clinical Research Source, Inc
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Neshaminy Medical, PC
City
Bensalem
State/Province
Pennsylvania
ZIP/Postal Code
19020
Country
United States
Facility Name
Westminster Family Medicine
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Feasterville Family Health Care Center
City
Feasterville
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
Southeastern Pennsylvania Medical Institute
City
Havertown
State/Province
Pennsylvania
ZIP/Postal Code
19083
Country
United States
Facility Name
Radiant Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Radiant Research - Anderson
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Amarillo Center for Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Walter F. Chase, M.D., P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Radiant Research Dallas North
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Quality Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Radiant Research - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Research Center, LLP
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Health Research of Hampton Roads, Inc.
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Tidewater Integrated Medical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23451
Country
United States
Facility Name
The Physicians Clinic of Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Advanced Healthcare
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21174485
Citation
Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000.
Results Reference
derived

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Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

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