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

October 11, 2010 updated by: Mika Pharma GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

650

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Mesa, Arizona, United States, 85206
      • Tucson, Arizona, United States, 85741
      • Tucson, Arizona, United States, 85710
    • California
      • Fair Oaks, California, United States, 95628
      • Pico Rivera, California, United States, 90660
      • Santa Barbara, California, United States, 93108
      • Torrance, California, United States, 90505
    • Florida
      • DeLand, Florida, United States, 32720
      • Jacksonville, Florida, United States, 32259
      • Kissimmee, Florida, United States, 34741
      • Ocala, Florida, United States, 34474
      • Ormond Beach, Florida, United States, 32174
      • Pembroke Pines, Florida, United States, 33024
      • Pinellas Park, Florida, United States, 33781
      • Stuart, Florida, United States, 34996
      • Tampa, Florida, United States, 33614
      • Tampa, Florida, United States, 33615
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Atlanta, Georgia, United States, 30308
      • Atlanta, Georgia, United States, 30329
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Gurnee, Illinois, United States, 60031
      • Morton, Illinois, United States, 61550
      • Peoria, Illinois, United States, 61614
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Louisiana
      • Baton-Rouge, Louisiana, United States, 70809
    • Missouri
      • Florissant, Missouri, United States, 63031
      • St Louis, Missouri, United States, 63141
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Columbus, Ohio, United States, 43212
      • Perrysburg, Ohio, United States, 43551
    • Pennsylvania
      • Wallingford, Pennsylvania, United States, 19086
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
    • Tennessee
      • Cordova, Tennessee, United States, 38018
      • Memphis, Tennessee, United States, 38119
    • Texas
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75235
      • San Antonio, Texas, United States, 78205
    • Virginia
      • Roanoke, Virginia, United States, 24018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: A
placebo
Other: placebo
ACTIVE_COMPARATOR: B
celecoxib 200 mg qd p.o.
Drug: celecoxib
EXPERIMENTAL: C
TDS-943 40 mg bid topically
Drug: TDS-943 (topical diclofenac sodium 4% spray)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the WOMAC Composite Pain Score
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mika Pharma GmbH

Investigators

  • Study Director: Medical Affairs, Mika Pharma GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

October 17, 2007

First Submitted That Met QC Criteria

October 17, 2007

First Posted (ESTIMATE)

October 19, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 13, 2010

Last Update Submitted That Met QC Criteria

October 11, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD-06-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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