Clinical trial NCT02596451: To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 1164
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
timeFrame: Baseline and week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Glenmark Investigational Site 5
state: Arizona
city: Anaheim
country: United States
facility: Glenmark Investigational Site 1
state: California
city: Anaheim
country: United States
facility: Glenmark Investigational Site 21
state: California
city: Anaheim
country: United States
facility: Glenmark Investigational Site 31
state: California
city: Canoga Park
country: United States
facility: Glenmark Investigational Site 26
state: California
city: Carlsbad
country: United States
facility: Glenmark Investigational Site 42
state: California
city: Carmichael
country: United States
facility: Glenmark Investigational Site 30
state: California
city: Cerritos
country: United States
facility: Glenmark Investigational Site 33
state: California
city: El Cajon
country: United States
facility: Glenmark Investigational Site 25
state: California
city: La Mesa
country: United States
facility: Glenmark Investigational Site 24
state: California
city: Pasadena
country: United States
facility: Glenmark Investigational Site 2
state: California
city: Rancho Cucamonga
country: United States
facility: Glenmark Investigational Site 13
state: California
city: Sacramento
country: United States
facility: Glenmark Investigational Site 27
state: California
city: Fort Lauderdale
country: United States
facility: Glenmark Investigational Site 10
state: Florida
city: Hialeah
country: United States
facility: Glenmark Investigational Site 41
state: Florida
city: Miami Lakes
country: United States
facility: Glenmark Investigational Site 3
state: Florida
city: Miami
country: United States
facility: Glenmark Investigational Site 15
state: Florida
city: Miami
country: United States
facility: Glenmark Investigational Site 19
state: Florida
city: Miami
country: United States
facility: Glenmark Investigational Site 28
state: Florida
city: Miami
country: United States
facility: Glenmark Investigational Site 32
state: Florida
city: Miami
country: United States
facility: Glenmark Investigational Site 40
state: Florida
city: Ormond Beach
country: United States
facility: Glenmark Investigational Site 37
state: Florida
city: West Palm Beach
country: United States
facility: Glenmark Investigational Site 11
state: Florida
city: West Palm Beach
country: United States
facility: Glenmark Investigational Site 18
state: Florida
city: Evanston
country: United States
facility: Glenmark Investigational Site 8
state: Illinois
city: Newburgh
country: United States
facility: Glenmark Investigational Site 43
state: Indiana
city: Wichita
country: United States
facility: Glenmark Investigational Site 38
state: Kansas
city: New Orleans
country: United States
facility: Glenmark Investigational Site 17
state: Louisiana
city: Saginaw
country: United States
facility: Glenmark Investigational Site 22
state: Michigan
city: Saint Louis
country: United States
facility: Glenmark Investigational Site 14
state: Missouri
city: Englewood
country: United States
facility: Glenmark Investigational Site 9
state: Ohio
city: Altoona
country: United States
facility: Glenmark Investigational Site7
state: Pennsylvania
city: Knoxville
country: United States
facility: Glenmark Investigational Site 36
state: Tennessee
city: Nashville
country: United States
facility: Glenmark Investigational Site 39
state: Tennessee
city: Beaumont
country: United States
facility: Glenmark Investigational Site 23
state: Texas
city: Bryan
country: United States
facility: Glenmark Investigational Site 20
state: Texas
city: Dallas
country: United States
facility: Glenmark Investigational Site 34
state: Texas
city: Houston
country: United States
facility: Glenmark Investigational Site 35
state: Texas
city: Houston
country: United States
facility: Glenmark Investigational Site 44
state: Texas
city: Lampasas
country: United States
facility: Glenmark Investigational Site 4
state: Texas
city: San Antonio
country: United States
facility: Glenmark Investigational Site 29
state: Texas
city: San Antonio
country: United States
facility: Glenmark Investigational Site 6
state: Texas
city: Charlottesville
country: United States
facility: Glenmark Investigational Site 16
state: Virginia
city: Midlothian
country: United States
facility: Glenmark Investigational Site12
state: Virginia
Study officials:
affiliation: Glenmark Pharmaceuticals Ltd
name: Mahesh V Deshpande
role: STUDY_DIRECTOR
References: