Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I
This study has been completed.
Sponsor:
Mika Pharma GmbH
Information provided by:
Mika Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00546507
First received: October 17, 2007
Last updated: October 11, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: TDS-943 (topical diclofenac sodium 4% spray) Drug: celecoxib Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study I |
Resource links provided by NLM:
Further study details as provided by Mika Pharma GmbH:
Primary Outcome Measures:
- Change from baseline in the WOMAC Composite Pain Score [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Enrollment: | 650 |
| Study Start Date: | October 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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) |
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546507
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Hide Study LocationsLocations
| United States, Alabama | |
| Huntsville, Alabama, United States, 35801 | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Mesa, Arizona, United States, 85206 | |
| Tucson, Arizona, United States, 85710 | |
| Tucson, Arizona, United States, 85741 | |
| United States, California | |
| Fair Oaks, California, United States, 95628 | |
| Pico Rivera, California, United States, 90660 | |
| Santa Barbara, California, United States, 93108 | |
| Torrance, California, United States, 90505 | |
| United States, 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, 33615 | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30308 | |
| Atlanta, Georgia, United States, 30329 | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60612 | |
| Gurnee, Illinois, United States, 60031 | |
| Morton, Illinois, United States, 61550 | |
| Peoria, Illinois, United States, 61614 | |
| United States, Indiana | |
| Evansville, Indiana, United States, 47714 | |
| United States, Louisiana | |
| Baton-Rouge, Louisiana, United States, 70809 | |
| United States, Missouri | |
| Florissant, Missouri, United States, 63031 | |
| St Louis, Missouri, United States, 63141 | |
| United States, North Carolina | |
| Raleigh, North Carolina, United States, 27612 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45219 | |
| Columbus, Ohio, United States, 43212 | |
| Perrysburg, Ohio, United States, 43551 | |
| United States, Pennsylvania | |
| Wallingford, Pennsylvania, United States, 19086 | |
| United States, Rhode Island | |
| Cranston, Rhode Island, United States, 02920 | |
| United States, Tennessee | |
| Cordova, Tennessee, United States, 38018 | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Dallas, Texas, United States, 75235 | |
| Dallas, Texas, United States, 75231 | |
| San Antonio, Texas, United States, 78205 | |
| United States, Virginia | |
| Roanoke, Virginia, United States, 24018 | |
Sponsors and Collaborators
Mika Pharma GmbH
Investigators
| Study Director: | Medical Affairs | Mika Pharma GmbH |
More Information
No publications provided
| Responsible Party: | Bernd G. Seigfried, MIKA Pharma GmbH |
| ClinicalTrials.gov Identifier: | NCT00546507 History of Changes |
| Other Study ID Numbers: | TD-06-13 |
| Study First Received: | October 17, 2007 |
| Last Updated: | October 11, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Diclofenac Celecoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Cyclooxygenase 2 Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013