OsteoarthritisPhase 3NCT00546832
Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II
A Phase 3 study testing TDS-943 (topical diclofenac sodium 4% spray) and celecoxib in people with Osteoarthritis, run by Mika Pharma GmbH at 49 sites in United States.
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
- 49 sitesUnited States
- Study dates
- Oct 2007to Nov 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
49 sites in 1 country.
49 sites in 1 country
United States49 sites
Study site
Anaheim, California, 92801
Study site
Anaheim, California, 92804
Study site
Asheville, North Carolina, 28801
Study site
Austin, Texas, 78704
Study site
Bensalem, Pennsylvania, 19020
Study site
Berlin, New Jersey, 08009
Study site
Birmingham, Alabama, 35209
Study site
Birmingham, Alabama, 35244
Study site
Blue Ridge, Georgia, 30513
Study site
Boise, Idaho, 83702
Study site
Boynton Beach, Florida, 33472
Study site
Brockton, Massachusetts, 02301
Study site
Brooklyn, New York, 11214
Study site
Chandler, Arizona, 85225
Study site
Charleston, South Carolina, 29406
Study site
Chicago, Illinois, 60611
Study site
Cincinnati, Ohio, 45246
Study site
Cleveland, Ohio, 44121
Study site
Danbury, Connecticut, 06810
Study site
Delray Beach, Florida, 33484
Study site
Denver, Colorado, 80209
Study site
Duncansville, Pennsylvania, 16635
Study site
Foothill Ranch, California, 92610
Study site
Irvine, California, 92618
Study site
Kalamazoo, Michigan, 49009
Study site
Kansas City, Missouri, 64114
Study site
Little Rock, Arkansas, 72205
Study site
Marietta, Georgia, 30066
Study site
Marion, Ohio, 43302
Study site
Medford, New Jersey, 08055
Study site
Milford, Connecticut, 06460
Study site
Milwaukee, Wisconsin, 53209
Study site
Nederland, Texas, 77627
Study site
New Smyrna Beach, Florida, 32168
Study site
Ococee, Florida, 34761
Study site
Oklahoma City, Oklahoma, 73103
Study site
Oklahoma City, Oklahoma, 73112
Study site
Omaha, Nebraska, 68144
Study site
Overland Park, Kansas, 66202
Study site
Phoenix, Arizona, 85032
Study site
San Antonio, Texas, 78209
Study site
San Antonio, Texas, 78229
Study site
Sarasota, Florida, 34239
Study site
Savannah, Georgia, 31406
Study site
St. Petersburg, Florida, 33702
Study site
Stanford, Connecticut, 06905
Study site
Towson, Maryland, 21286
Study site
Virginia Beach, Virginia, 23455
Study site
Westlake Village, California, 91361
About this study
Official title: The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study II
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 group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo Receives: Other: placebo |
| 2 | Active comparator | celecoxib 200 mg qd p.o. Receives: Drug: celecoxib |
| 3 | Experimental | TDS-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.
Change from baseline in the WOMAC Composite Pain Score
Measured: 30 days
Secondary outcomes (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.
- First posted19 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mika Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Affairs, Study director, Mika Pharma GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546832
- Sponsor's protocol ID
- TD-07-14
- Status last verified
- Oct 2010
- First submitted
- 17 Oct 2007
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study II
- ClinicalTrials.gov ID
- NCT00546832
- Acronym / sponsor ID
- TD-07-14
- Conditions
- Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Mika Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 19 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: placeboplacebo |
| 2 | Active comparator | Drug: celecoxibcelecoxib 200 mg qd p.o. |
| 3 | Experimental | Drug: TDS-943 (topical diclofenac sodium 4% spray)TDS-943 40 mg bid topically |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDS-943 (topical diclofenac sodium 4% spray) | Drug | 3 |
| celecoxib | Drug | 2 |
| placebo | Other | 1 |
Primary outcome
Change from baseline in the WOMAC Composite Pain Score
Time frame: 30 days
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Affairs study director
Mika Pharma GmbH
49 sites in 1 country: see every site and its status.
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 49 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 49 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?
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.