Back to resultsStudy Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TDS-943 (topical diclofenac sodium 4% spray)
celecoxib
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Males or females in generally good health at least 40 years of age
- Osteoarthritis (OA) of at least one knee, verified by a weight-bearing radiograph
- Subject has taken an oral NSAID or analgesic at least 3 days during the past 30 days to treat knee OA pain
Exclusion Criteria:
- Females who are pregnant or lactating or who may become pregnant
- Hypersensitivity (exacerbations of asthma, rhinitis, or urticaria) to sulfonamides, acetaminophen, diclofenac, celecoxib, aspirin, or any other NSAID
- History of myocardial infarction, congestive heart failure, stroke, coronary-artery bypass graft surgery, or any other significant cardiovascular disease, or is on any form of anticoagulation therapy other than low-dose aspirin (no more than 325 mg/day)
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
placebo
celecoxib 200 mg qd p.o.
TDS-943 40 mg bid topically
Outcomes
Primary Outcome Measures
Change from baseline in the WOMAC Composite Pain Score
Secondary Outcome Measures
Change from baseline in the WOMAC Composite Stiffness and Composite Function Scores, Change from Baseline in the Subject's Global Assessment of Arthritic Condition, Change from baseline in the Subject's Assessment of OA Pain, %OMERACT-OARSI responders
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00546832
Brief Title
Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II
Official Title
The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study II
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mika Pharma GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than celecoxib.
Detailed Description
This is a multicenter, outpatient, multiple-dose, placebo- and active controlled, double-blind, double-dummy parallel group, randomized (stratified by unilateral vs. bilateral knee OA) trial. The trial will enroll subjects who have been diagnosed with OA of the knee (confirmed by weight-bearing x-ray) and whose condition is in flare at baseline. Subjects who qualify to enter the study will be randomized to topical TDS-943 40 mg bid, oral celecoxib 200 mg qd, or placebo in a 3:2:2 ratio.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
650 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
celecoxib 200 mg qd p.o.
Arm Title
3
Arm Type
Experimental
Arm Description
TDS-943 40 mg bid topically
Intervention Type
Drug
Intervention Name(s)
TDS-943 (topical diclofenac sodium 4% spray)
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change from baseline in the WOMAC Composite Pain Score
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change from baseline in the WOMAC Composite Stiffness and Composite Function Scores, Change from Baseline in the Subject's Global Assessment of Arthritic Condition, Change from baseline in the Subject's Assessment of OA Pain, %OMERACT-OARSI responders
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females in generally good health at least 40 years of age
Osteoarthritis (OA) of at least one knee, verified by a weight-bearing radiograph
Subject has taken an oral NSAID or analgesic at least 3 days during the past 30 days to treat knee OA pain
Exclusion Criteria:
Females who are pregnant or lactating or who may become pregnant
Hypersensitivity (exacerbations of asthma, rhinitis, or urticaria) to sulfonamides, acetaminophen, diclofenac, celecoxib, aspirin, or any other NSAID
History of myocardial infarction, congestive heart failure, stroke, coronary-artery bypass graft surgery, or any other significant cardiovascular disease, or is on any form of anticoagulation therapy other than low-dose aspirin (no more than 325 mg/day)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Affairs
Organizational Affiliation
Mika Pharma GmbH
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
City
Stanford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
City
Ococee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
City
Medford
State/Province
New Jersey
ZIP/Postal Code
08055
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Bensalem
State/Province
Pennsylvania
ZIP/Postal Code
19020
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
City
Nederland
State/Province
Texas
ZIP/Postal Code
77627
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II
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