Osteoarthritis
Conditions
Brief summary
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee
Interventions
DRUGDiclofenac Sodium gel, 1%
DRUGVoltaren® Gel
DRUGPlacebo
Sponsors
Glenmark Pharmaceuticals Ltd. India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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. 2. OA Symptoms for at least 6 months prior to screening. 3. Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of \> 9 on a 20 point scale for the target knee immediately prior to randomization.
Exclusion criteria
1. History of OA pain in the contralateral knee requiring medication within 1 year prior to screening. 2. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia. 3. History of gastrointestinal bleeding or peptic ulcer disease. 4. Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID). 5. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening. 6. Concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee | Baseline and week 4 | The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Diclofenac Sodium gel, 1% (Glenmark Pharmaceuticals Ltd) | 383 |
| Reference Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) | 382 |
| Placebo Vehicle gel (Glenmark Pharmaceuticals Ltd) | 378 |
| Total | 1,143 |
Baseline characteristics
| Characteristic | Test | Reference | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 10.36 | 56.5 years STANDARD_DEVIATION 10.68 | 56.7 years STANDARD_DEVIATION 10.52 | 56.4 years STANDARD_DEVIATION 10.51 |
| Sex: Female, Male Female | 249 Participants | 237 Participants | 248 Participants | 734 Participants |
| Sex: Female, Male Male | 134 Participants | 145 Participants | 130 Participants | 409 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 383 | 26 / 382 | 23 / 378 |
| serious Total, serious adverse events | 0 / 383 | 2 / 382 | 1 / 378 |
Outcome results
Primary
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.
Time frame: Baseline and week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee | 5.8 units on a scale | Standard Deviation 3.96 |
| Reference | Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee | 5.9 units on a scale | Standard Deviation 3.94 |