Phase 3
Completed N=1,220
A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT03172780 ↗
Enrolled (actual)
1,220
Serious AEs
0.1%
Results posted
Apr 2021
Primary outcomePrimary: Mean Change in the Total WOMAC Pain Subscale Score — -4.3; -4.6 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of osteoarthritis of knee compared to Voltaren® gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel.
Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria
Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in the Total WOMAC Pain Subscale Score |
-4.3; -4.6 | — |
| PRIMARY Change From Baseline in WOMAC Pain Subscale Score |
-4.2; -4.4; -3.2 | — |
Eligibility Criteria
Inclusion Criteria
- Osteoarthritis knee as per American College of Rheumatology (ACR) criteria
- Evidence of OA with Kellgren-Lawrence grade 1-3 disease.
- After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
- After discontinuing all pain medications 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.
- Able to tolerate rescue medication with acetaminophen
- Subjects who can read and understand WOMAC pain sub scale
Exclusion Criteria
- Pregnancy, lactation
- OA of Kellgren-Lawrence grade 4
- OA pain in the contralateral knee requiring medication (OTC or prescription)
- History of OA of either Hip or Hands
- History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
- History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
- History of Drugs or Alcohol abuse within the previous year
- Symptomatic peripheral vascular disease of the study leg
- Any musculoskeletal condition
- Skin disease at the application site
- Active asthma requiring periodic treatment with systemic steroids
- Known history of positive HIV, hepatitis C virus, or HBsAg
- Uncontrolled hypertension
- History of myocardial infarction, thrombotic events, stroke etc.
- Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).
Data sourced from ClinicalTrials.gov (NCT03172780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.