EUCTR2012-002682-36-HUActive, not recruitingNot Applicable
Comparison of the Efficacy of Diclofenac Sodium Topical Gel, 1% (Mylan) to Voltaren® Gel, 1% (Novartis US) and Placebo in Adult Subjects with Knee Osteoarthritis
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Mylan Pharmaceuticals Inc.
- Enrollment
- 1,600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Male and Female subjects aged 35 years or older with a clinical diagnosis of
- •osteoarthritis of the knee according to the American College of Rheumatology (ACR)
- •1. knee pain plus 3 of the following:
- •a. 50 years of age or older
- •b. stiffness lasting less than 30 minutes,
- •c. crepitus,
- •d. bony tenderness,
- •e. bony enlargement,
- •f. no warmth to the touch,
- •and including:
- •2. Symptoms for at least 6 months prior to screening; AND
- •3. Knee pain (not referred) for at least 15 days of the preceding month (30 days)
- •(periarticular knee pain due to osteoarthritis and not due to other conditions such
- •as bursitis, tendonitis, etc); AND
- •4. the pain in the target knee required the daily use of non-steroidal antiinflammatory
- •drugs (NSAIDS) or acetaminophen/paracetamol (topical or oral
- •treatments);
- •5. Had an X-ray of the target knee, taken no more than 1 year before the initiation of
- •the study, demonstrating evidence of osteoarthritis with Kellgren-Lawrence grade
- •1-3 disease;
- •6. After discontinuing their current regimen of analgesic(s) for a period of at least 7 days or = 5 half-lives of the mean half-life of their previous analgesic, which ever is longer,had at least moderate pain on movement (POM) in the target knee, defined as a baseline score of = 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to randomization, AND a baseline Western Ontario McMaster Osteoarthritis (WOMAC®) pain subscale of at least 9 immediately prior to randomization; and
- •7. Willing to use and able to tolerate the rescue medication
- •(acetaminophen/paracetamol)
- •- Males and non-pregnant, non-lactating females weighing at least 50 kg and 48 kg,
- •respectively
- •- Subjects judged by Principal Investigator or Medical Sub-investigator as otherwise
- •normal and healthy during a pre-study medical evaluation including physical
- •examination, vital signs (respiration rate, blood pressure, temperature, and heart rate),
- •within normal limits or not clinically significant laboratory results for serum
- •chemistries, hematology and urinalysis.
- •- Negative Hepatitis B, Hepatitis C, and HIV test
- •- Negative urine drugs of abuse screen
- •- Normal or not clinically significant electrocardiogram (EKG/ECG).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
Exclusion Criteria
- •1. Institutionalized subjects will not be used.
- •2. History of drug and/or alcohol abuse.
- •3. Women who are pregnant, lactating, or planning to become pregnant during the
- •study period.ALT (SGPT) and AST (SGOT) values higher than 3.0 times the upper limit of normal.
- •4. Social Habits:
- •a. Alcohol consumption greater than 15 units of alcohol per week with 1 unit equivalent to 12 oz of beer (350 mL), 4 oz of wine (120 mL), or 1.5 oz (45mL) of 80 proof (40% alcohol) distilled spirits,
- •b. Caffeine ingestion greater than 5 cups (180 mL/cup) of coffee or its equivalent of caffeine- or xanthine-containing foods or beverages per day.
- •c. Ingestion of any vitamin or herbal supplement known to induce or inhibit hepatic enzyme activity within 7 days prior to the initial dose of study medication. (see Sec 18. Hepatic Enzyme Inducers and Inhibitors List).
- •d. Any recent, significant change in dietary or exercise habits.
- •5. Medications:
- •a. All concomitant medications will be documented. Individuals receiving
- •medications with clinically significant drug-drug interactions with diclofenac
- •or other non-steroidal anti-inflammatory drugs (NSAIDs) will be excluded
- •unless the drug can be safely discontinued.
- •b. Use of anticoagulants, ACE-inhibitors, cyclosporine, tacrolimus, sirolimus, diuretics, lithium, methotrexate within 30 days prior to the first dose of study medication. Stable doses of ACE-inhibitors and diuretics will be allowed if taken for at least 3 months prior to enrollment and maintained throughout the study.
- •c. Use of intra-articular hyaluronic acid injections with in 6 months of study start.
- •d. Use of pain medication (e.g. NSAIDs, opioids, muscle relaxants) within the last 7 days prior to the first dose of study medication.
- •e. Use of acetaminophen (paracetamol) during the 24 hours prior to the
- •randomization visit.
- •f. Use of aspirin (acetylsalicylic acid) therapy other than a stable low dose used for cardiac prophylaxis (= 162 mg/day) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
- •g. Use of glucosamine, chondroitin, systemic or topical corticosteroids within 30 days of the first dose of study medication.
- •h. Diacerein (also known as Diacetylrhein), and ASU (Avocado-Soybean
- •Unsaponificable) within 30 days of the first dose of study medication.
- •i. Use of occlusive bandages, ultrasound, transcutaneous electrical stimulation or any alternative therapies such as acupuncture, homeopathy, or mesotherapy for the treatment of osteoarthritis within 7 days of the first dose of study medication.
- •j. Use of any medication known to induce or inhibit hepatic enzyme activity
- •within 30 days prior to the first dose of study medication except for those agents expressly allowed. (see Sec 18. Hepatic Enzyme and Inhibitors List).
- •6. Diseases:
- •a. History of osteoarthritic (OA) pain in the contralateral knee requiring
- •medication within 1 year prior to screening.
- •b. After discontinuing all pain medication for at least 7 days, had a baseline score
- •of = 20 mm on 0-100 mm Visual Analog Scale (VAS) for POM in the
- •contralateral knee immediately prior to randomization.
- •c. History of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis),
- •rheumatoid arthritis, chronic inflammatory disease (e.g. colitis) or
- •fibromyalgia.
- •d. History of gastrointestinal bleeding or peptic ulcer disease.
- •e. X-ray showing evidence of osteoarthritis with Kellgren-Lawrence grade 4 disease.
- •f. History of any significant or unstable card
Investigators
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