Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%
NCT ID: NCT01456611
Last Updated: 2012-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
749 participants
INTERVENTIONAL
2011-09-30
2012-04-30
Brief Summary
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The efficacy of both the Test and Reference formulations will also be compared to the Placebo gel to determine Superiority.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Diclofenac Sodium Gel
Diclofenac sodium Topical Gel 1%
Diclofenac
Diclofenac Sodium Gel 1%
Voltaren (R) Gel
Voltaren (R) Gel 1%
Diclofenac
Diclofenac Sodium Gel 1%
Placebo
Placebo Topical Gel
Placebo
Placebo Topical Gel
Interventions
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Diclofenac
Diclofenac Sodium Gel 1%
Placebo
Placebo Topical Gel
Eligibility Criteria
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Inclusion Criteria
ACR Criteria includes, Knee Pain and at least 3 of the following:
1. age ≥ 50
2. stiffness lasting \< 30 mins
3. bony tenderness
4. crepitus
5. bony enlargement
6. no palpable warmth
2\. Symptom onset of \> 6 Months prior to Screening for the target knee.
3\. If female and of child-bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom + spermicide, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
4\. Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc) requiring the use of oral or topical treatments (NSAIDS or acetaminophen) for \> 15 days in the 30 days prior to Screening.
5\. Radiograph of the target knee within the previous year with a Grade 1, 2 or 3 disease based upon the Kellgren-Lawrence disease severity scale.
6\. After a 7 day wash out of all pain medication has baseline pain on movement score of ≥ 50mm on a 100-mm Visual Analogue Scale for the target knee.
7\. After a 7 day wash out of all pain medication has baseline WOMAC pain sub scale of ≥ 9 on a 5 question, 5 point (0 to 4) Likert scale for the target knee.
8\. Willing and able to use only acetaminophen as rescue medication
9\. Willing and able to comply with the study requirements.
Exclusion Criteria
2. Radiograph of the target knee within the previous year with a Grade 4 score on the Kellgren-Lawrence disease severity scale. 24
3. History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
4. After a 7 day wash out of all pain medication has baseline pain on movement score of ≥ 20mm on a 100-mm Visual Analogue Scale for the contralateral knee immediately prior to randomization.
5. Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) or rheumatoid arthritis.
6. Known history of other chronic inflammatory diseases, (e.g.,colitis) or fibromyalgia.
7. History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
8. History of coronary artery bypass graft within 6 months of screening.
9. Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max 162mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
10. Use of warfarin or other anticoagulant therapy within 30 days of screening.
11. Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of screening or during the study.
12. Known history of gastrointestinal bleeding or peptic ulcer disease.
13. Abnormal screening clinical laboratory evaluations which the Investigator determines are clinically significant.
14. Known allergy to aspirin or NSAIDs.
15. Results from liver function tests that are more than two times the upper limit of the normal range at screening.
16. Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the Patient at risk by participating in the study.
17. Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization.
18. Receipt of any drug as part of a research study within 30 days prior to screening.
19. Previous participation in this study.
35 Years
ALL
No
Sponsors
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Novum Pharmaceutical Research Services
INDUSTRY
Anchen Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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Novum Investigator Site
Birmingham, Alabama, United States
Novum Investigator Site
Huntsville, Alabama, United States
Novum Investigator Site
Chandler, Arizona, United States
Novum Investigator Site
Mesa, Arizona, United States
Novum Investigator Site
Phoenix, Arizona, United States
Novum Investigator Site
Tuscon, Arizona, United States
Novum Investigator Site
Little Rock, Arkansas, United States
Novum Investigator Site
Anaheim, California, United States
Novum Investigator Site
Carmichael, California, United States
Novum Investigator Site
Garden Grove, California, United States
Novum Investigator Site
Long Beach, California, United States
Novum Investigator Site
Sacramento, California, United States
Novum Investigator Site
San Diego, California, United States
Novum Investigator Site
Stock Bridge, California, United States
Novum Investigator Site
Denver, Colorado, United States
Novum Investigator Site
Norwalk, Connecticut, United States
Novum Investigator Site
Stamford, Connecticut, United States
Novum Investigator Site
Adventura, Florida, United States
Novum Investigator Site
Bookville, Florida, United States
Novum Investigator Site
Bradenton, Florida, United States
Novum Investigator Site
Daytona Beach, Florida, United States
Novum Investigator Site
Hialeah, Florida, United States
Novum Investigator Site
Jupiter, Florida, United States
Novum Investigator Site
Miami, Florida, United States
Novum Investigator Site
Ormond Beach, Florida, United States
Novum Investigator Site
Pinellas Park, Florida, United States
Novum Investigator Site
Sarasota, Florida, United States
Novum Investigator Site
St. Petersburg, Florida, United States
Novum Investigator Site
Tampa, Florida, United States
Novum Investigator Site
Marietta, Georgia, United States
Novum Investigator Site
Sandy Springs, Georgia, United States
Novum Investigator Site
Lexington, Kentucky, United States
Novum Investigator Site
New Orleans1, Louisiana, United States
Novum Investigator Site
Hollywood, Maryland, United States
Novum Investigator Site
Billings, Montana, United States
Novum Investigator Site
Henderson, Nevada, United States
Novum Investigator Site
Cary, North Carolina, United States
Novum Investigator Site
Charlotte, North Carolina, United States
Novum Investigator Site
Hickory, North Carolina, United States
Novum Investigator Site
High Point, North Carolina, United States
Novum Investigator Site
Raleigh, North Carolina, United States
Novum Investigator Site
Salisbury, North Carolina, United States
Novum Investigator Site
Wilmington, North Carolina, United States
Novum Investigator Site
Winston-Salem, North Carolina, United States
Novum Investigator Site
Cleveland, Ohio, United States
Novum Investigator Site
Columbus, Ohio, United States
Novum Investigator Site
Beavercreek, Oklahoma, United States
Novum Investigator Site
Norman, Oklahoma, United States
Novum Investigator Site
Duncansville, Pennsylvania, United States
Novum Investigator Site
Chattanooga, Tennessee, United States
Novum Investigator Site
Houston, Texas, United States
Novum Investigator Site
Longview, Texas, United States
Novum Investigator Site
San Antonio, Texas, United States
Novum Investigator Site
Sugar Land, Texas, United States
Novum Investigator Site
Charlottesville, Virginia, United States
Novum Investigator Site
Midlothian, Virginia, United States
Novum Investigator Site
Newport News, Virginia, United States
Countries
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Other Identifiers
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DCL-269
Identifier Type: -
Identifier Source: org_study_id