Bioequivalence study with clinical endpoint of generic diclofenac gel withVoltaren® gel in patients with osteoarthritis of knee.
- Conditions
- Health Condition 1: null- Osteoarthritis (OA) of the Knee
- Registration Number
- CTRI/2017/04/008304
- Lead Sponsor
- Mylan Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1220
1. Healthy male or non-pregnant female aged >= 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria i.e. Knee pain along with at least 3 of the following 6 criteria
a. Age > 50 years
b. Stiffness < 30 minutes
c. Presence of crepitus
d. Bony tenderness
e. Bony enlargement
f. No palpable warmth
2. Symptoms in target knee for at least 6 months prior to screening
3. Knee (not referred) pain in target knee for 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.)
4. Pain in the target knee requiring the use of NSAIDs or acetaminophen/paracetamol (topical or oral treatments).
5. Subject having an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
6. After discontinuing all pain medications (placebo run â?? in period) for at least 7 days, had at least moderate pain on movement (POM) for target knee, defined as a baseline score of >= 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to randomization
7. After discontinuing all pain medications (placebo run â?? in period) for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of >=9 immediately prior to randomization.
8. Able to tolerate rescue medication with acetaminophen (paracetamol) taken as l-2 tablets up to a maximum 2 gm per day for the duration of the study.
9. Subjects who can read and understand WOMAC pain sub scale.
10. If female, patient must be either postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing the following methods of birth control:
a) Oral Contraceptives or Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
b) Double Barrier methods containing or used in conjunction with a spermicidal agent, or
c) Contraceptive Patches/ Implants, or
d) Abstinence: Subjects who will be practicing abstinence will agree to have a documented second acceptable method of birth control if the subject become sexually active during the course of her study participation.
1. Pregnant or lactating or planning to become pregnant during the study period.
2. X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
3. History of OA pain in the contralateral knee requiring medication (OTC or prescription) within 1 year prior to screening.
4. After discontinuing all pain medications (placebo run-in period) for at least 7 days, had a baseline score of >= 20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization.
5. History of OA of either Hip or Hands
6. History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis.
7. History of chronic inflammatory disease (e.g., colitis) or fibromyalgia.
8. History of Drugs or Alcohol abuse within the previous year.
9. Symptomatic peripheral vascular disease of the study leg (prior or current).
10. Any musculoskeletal condition that would impede measurement of efficacy at the target knee.
11. History of regular headaches or backache which warrants often use of acetaminophen (paracetamol) within the previous year.
12. Concomitant skin disease at the application site which may affect study drug application or tolerability evaluation.
13. History of active asthma within the previous year that may require periodic treatment with systemic steroids during the study period (note: inhaled steroids for this condition are allowed).
14. History of aspirin sensitive asthma.
15. History of uncontrolled hypertension (blood pressure more than 150/100 mm of Hg) in spite of treatment within the previous year.
16. History of myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function (Serum creatinine > 1.5 x ULN) or liver disease within the previous year.
17. History of coronary artery bypass graft within 6 months of screening.
18. History of gastrointestinal bleeding or peptic ulcer disease in last one year.
19. Known allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).
20. Elevated transaminases (>= 3 times ULN) and Hemoglobin Ë? 9.0 g/dL at screening.
21. Viscosupplementation in any joint including the target knee within 6 months prior to screening
22. Receiving physical therapy (at an outpatient/clinic setting) for the lower extremities or having received physical therapy for the lower extremities within 1 month before screening.
23. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.
24. Concomitant use of intra articular corticosteroids, systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.
25. Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (maximum 162 mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
26. History of major surgery or previous damage to the study knee at any time, or minor knee surgery (e.g. any surgery other than major surgery including, but not limited to, cartilage repair, collateral ligament repair, or arthroscopic debridement) to the study knee within 1 year prior to screening.
27. Known history of positive HIV, HCV, or HBsAg.
28. Tense effusion requiring aspir
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Mean change in the total WOMAC pain subscale score for the target knee, from baseline to week 4Timepoint: â?¢Mean change in the total WOMAC pain subscale score for the target knee, from baseline to week 4
- Secondary Outcome Measures
Name Time Method â?¢Mean change in the total WOMAC pain subscale score for the target knee, from baseline to week 2. <br/ ><br>â?¢Mean change in the WOMAC pain subscale score at week 4 for subgroup subjects whose baseline WOMAC pain score less than or equal to 10.Timepoint: 2 and 4 week