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Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

TDS-943 (topical diclofenac sodium 4% spray)

celecoxib

placebo

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

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

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

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

NCT ID

NCT00546507

First Posted

October 17, 2007

Last Updated

October 11, 2010

Sponsor

Mika Pharma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00546507

Brief Title

Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I

Official Title

The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study I

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

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mika Pharma GmbH

4. Oversight

Data Monitoring Committee

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

Arm Type

Placebo Comparator

Arm Description

placebo

Arm Title

Arm Type

Active Comparator

Arm Description

celecoxib 200 mg qd p.o.

Arm Title

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

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85710

Country

United States

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

City

Fair Oaks

State/Province

California

ZIP/Postal Code

95628

Country

United States

City

Pico Rivera

State/Province

California

ZIP/Postal Code

90660

Country

United States

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93108

Country

United States

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32259

Country

United States

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

City

Ocala

State/Province

Florida

ZIP/Postal Code

34474

Country

United States

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

City

Stuart

State/Province

Florida

ZIP/Postal Code

34996

Country

United States

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

City

Tampa

State/Province

Florida

ZIP/Postal Code

33615

Country

United States

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30329

Country

United States

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

City

Gurnee

State/Province

Illinois

ZIP/Postal Code

60031

Country

United States

City

Morton

State/Province

Illinois

ZIP/Postal Code

61550

Country

United States

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61614

Country

United States

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

City

Baton-Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

City

Florissant

State/Province

Missouri

ZIP/Postal Code

63031

Country

United States

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

City

Perrysburg

State/Province

Ohio

ZIP/Postal Code

43551

Country

United States

City

Wallingford

State/Province

Pennsylvania

ZIP/Postal Code

19086

Country

United States

City

Cranston

State/Province

Rhode Island

ZIP/Postal Code

02920

Country

United States

City

Cordova

State/Province

Tennessee

ZIP/Postal Code

38018

Country

United States

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78205

Country

United States

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24018

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 I

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