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OsteoarthritisPhase 3NCT00546507

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

A Phase 3 study testing TDS-943 (topical diclofenac sodium 4% spray) and celecoxib in people with Osteoarthritis, run by Mika Pharma GmbH at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
TDS-943 (topical diclofenac sodium 4% spray) and celecoxib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
650 participants
Where
43 sitesUnited States
Study dates
Oct 2007to Oct 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Atlanta, Georgia, 30329

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Baton Rouge, Louisiana, 70809

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Columbus, Ohio, 43212

  • Study site

    Cordova, Tennessee, 38018

  • Study site

    Cranston, Rhode Island, 02920

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75235

  • Study site

    DeLand, Florida, 32720

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fair Oaks, California, 95628

  • Study site

    Florissant, Missouri, 63031

  • Study site

    Gurnee, Illinois, 60031

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Jacksonville, Florida, 32259

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    Mesa, Arizona, 85206

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Morton, Illinois, 61550

  • Study site

    Ocala, Florida, 34474

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Pembroke Pines, Florida, 33024

  • Study site

    Peoria, Illinois, 61614

  • Study site

    Perrysburg, Ohio, 43551

  • Study site

    Pico Rivera, California, 90660

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Roanoke, Virginia, 24018

  • Study site

    San Antonio, Texas, 78205

  • Study site

    Santa Barbara, California, 93108

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Stuart, Florida, 34996

  • Study site

    Tampa, Florida, 33614

  • Study site

    Tampa, Florida, 33615

  • Study site

    Torrance, California, 90505

  • Study site

    Tucson, Arizona, 85710

  • Study site

    Tucson, Arizona, 85741

  • Study site

    Wallingford, Pennsylvania, 19086

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Osteoarthritis
Being tested
TDS-943 (topical diclofenac sodium 4% spray), celecoxib, placebo
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TDS-943 (topical diclofenac sodium 4% spray)Drug

  • celecoxibDrug

  • placeboOther

Study groups in NCT00546507
Study groupRoleWhat they receive
APlacebo comparatorplacebo
Receives: Other: placebo
BActive comparatorcelecoxib 200 mg qd p.o.
Receives: Drug: celecoxib
CExperimentalTDS-943 40 mg bid topically
Receives: Drug: TDS-943 (topical diclofenac sodium 4% spray)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the WOMAC Composite Pain Score

    Measured: 30 days

Secondary outcomes (1)

  1. 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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00546507
Sponsor's protocol ID
TD-06-13
Status last verified
Oct 2010
First submitted
17 Oct 2007
Last updated
13 Oct 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TDS-943 (topical diclofenac sodium 4% spray) and celecoxib in people with Osteoarthritis, run by Mika Pharma GmbH at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the WOMAC Composite Pain Score (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00546507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.

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