Study to evaluate the bioequivalence of Diclofenac diethylamine gel, 1.16% in subjects with Osteoarthritis Degenerative joint disease of the knee.
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2023/12/060871
- Lead Sponsor
- Encube Ethical Private Limited, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Males or non-pregnant, non-lactating females aged = 35 years with a clinical diagnosis of
osteoarthritis of the knee according to the American College of Rheumatology criteria, i.e.
Knee pain along with at least 3 of the following 6 criteria (Appendix I)
Age > 50 years
Stiffness < 30 minutes
Presence of crepitus
Bony tenderness
Bony enlargement
No palpable warmth
2. Symptoms in the target knee for at least 6 months prior to screening
3. Knee pain for 15 days of the preceding month (periarticular knee pain due to osteoarthritis and
not due to other conditions such as bursitis, tendonitis, etc.)
4. The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (NSAID)
5.Patients 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 (Appendix no. II)
Note: If a digital x-ray (both anterior-posterior and lateral view) of the target knee taken no
more than 1 year before baseline is available then the findings of the available x-ray will be considered for evaluation and no repeat x-ray will be performed.
6. After discontinuation of all pain medications for at least 7 days (Placebo run-in period), have
found at least moderate pain on movement (POM) for the target knee, defined as a baseline.
score of = 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to
randomization (Appendix III)
7. After discontinuation of all pain medications for at least 7 days (Placebo run-in period), a
baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert,
Version 3.1) pain subscale of = 9 immediately prior to randomization (Appendix IV)
8. Able to replace all current pain medications with acetaminophen for use as needed during the
duration of the study [subject should be able to withhold all rescue medication (e.g.,
acetaminophen) use for at least 48 hours prior to all WOMAC pain score assessments at study.
visits
9. Change in the total WOMAC pain subscale score for the target knee = 2 from Visit 2 (Start of
Placebo Run-in period) to Visit 3 (Baseline/Randomization).
10. Subjects who can read and understand the WOMAC pain sub-scale.
11. Patients who are able to understand the investigational nature of this study and able to provide
a written informed consent form
12. Patients who are willing and able to comply with all the study assessments and adhere to the
protocol schedule
13. If female, the 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:
o Oral Contraceptives or Intrauterine Devices in place for at least 3 months prior to the
start of the study and remaining in place during the study period, or
o Double Barrier methods containing or used in conjunction with a spermicidal agent, or
o Contraceptive Patches/ Implants, or
o Abstinence: Subjects who will be practicing abstinence will agree to have a documented
second acceptable method of birth control if the subject becomes sexually active during
the course of her study particip
1. Known history or presence of hypersensitivity or allergic reaction to Diclofenac, aspirin,
acetaminophen, or other NSAIDs, or any other inactive ingredients used in the study product
2. Females who are pregnant or lactating or planning to become pregnant during the study period
3. The X-ray confirmed Kellgren-Lawrence Grade 4 disease of Osteoarthritis
4. History of OA pain in the contralateral knee requiring medication (OTC or prescription) within
1 year prior to screening
5. After discontinuation of all pain medications for at least 7 days (Placebo run-in period), had a
baseline score of = 20 mm on a 0-100 mm VAS for the contralateral knee immediately prior to
randomization
6. History of OA of either Hip or Hands.
7. History or presence of secondary OA (e.g. Congenital, traumatic, gouty arthritis), rheumatoid
arthritis
8. History or presence of chronic inflammatory disease (e.g. colitis) or fibromyalgia
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 or condition that warrants frequent use of
acetaminophen (paracetamol) or NSAIDs within the previous year.
12. Concomitant skin disease at the application site 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 uncontrolled hypertension (blood pressure more than 150/100 mm of Hg) in spite of
treatment within the previous year and/or any other clinically significant vital sign abnormality.
15. History of aspirin-sensitive asthma
16. History of myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired
renal function (Serum creatinine > 1.5 x ULN), or liver disease within 1 year of randomization
17. History of gastrointestinal bleeding or peptic ulcer disease in the last year
18. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within
the past month prior to entry into the study
19. Elevated transaminases (= 3 times ULN) and hemoglobin < 9.0 g/dL at screening
20. Concomitant use of intra-articular corticosteroids, systemic corticosteroids, topical
corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening
21. Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac
prophylaxis (maximum 162 mg daily) was taken for at least 3 months prior to enrolment and
maintained throughout the duration of the study.
22. 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
23. Visco-supplementation in any joint including the target knee within 6 months prior to
screening.
24. Tense effusion requiring aspiration.
25. Known history of positive serology test i.e., HIV, HC
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method