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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).

NCT ID: NCT02596451

Last Updated: 2017-06-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Diclofenac Sodium gel, 1%

apply gel to the target knee

Group Type EXPERIMENTAL

Diclofenac Sodium gel, 1%

Intervention Type DRUG

Voltaren® Gel

apply gel to the target knee

Group Type ACTIVE_COMPARATOR

Voltaren® Gel

Intervention Type DRUG

Placebo

apply gel to the target knee

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Diclofenac Sodium gel, 1%

Intervention Type DRUG

Voltaren® Gel

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glenmark Pharmaceuticals Ltd. India

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahesh V Deshpande

Role: STUDY_DIRECTOR

Glenmark Pharmaceuticals Ltd

Locations

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Glenmark Investigational Site 5

Mesa, Arizona, United States

Site Status

Glenmark Investigational Site 1

Anaheim, California, United States

Site Status

Glenmark Investigational Site 21

Anaheim, California, United States

Site Status

Glenmark Investigational Site 31

Anaheim, California, United States

Site Status

Glenmark Investigational Site 26

Canoga Park, California, United States

Site Status

Glenmark Investigational Site 42

Carlsbad, California, United States

Site Status

Glenmark Investigational Site 30

Carmichael, California, United States

Site Status

Glenmark Investigational Site 33

Cerritos, California, United States

Site Status

Glenmark Investigational Site 25

El Cajon, California, United States

Site Status

Glenmark Investigational Site 24

La Mesa, California, United States

Site Status

Glenmark Investigational Site 2

Pasadena, California, United States

Site Status

Glenmark Investigational Site 13

Rancho Cucamonga, California, United States

Site Status

Glenmark Investigational Site 27

Sacramento, California, United States

Site Status

Glenmark Investigational Site 10

Fort Lauderdale, Florida, United States

Site Status

Glenmark Investigational Site 41

Hialeah, Florida, United States

Site Status

Glenmark Investigational Site 15

Miami, Florida, United States

Site Status

Glenmark Investigational Site 19

Miami, Florida, United States

Site Status

Glenmark Investigational Site 28

Miami, Florida, United States

Site Status

Glenmark Investigational Site 32

Miami, Florida, United States

Site Status

Glenmark Investigational Site 40

Miami, Florida, United States

Site Status

Glenmark Investigational Site 3

Miami Lakes, Florida, United States

Site Status

Glenmark Investigational Site 37

Ormond Beach, Florida, United States

Site Status

Glenmark Investigational Site 11

West Palm Beach, Florida, United States

Site Status

Glenmark Investigational Site 18

West Palm Beach, Florida, United States

Site Status

Glenmark Investigational Site 8

Evanston, Illinois, United States

Site Status

Glenmark Investigational Site 43

Newburgh, Indiana, United States

Site Status

Glenmark Investigational Site 38

Wichita, Kansas, United States

Site Status

Glenmark Investigational Site 17

New Orleans, Louisiana, United States

Site Status

Glenmark Investigational Site 22

Saginaw, Michigan, United States

Site Status

Glenmark Investigational Site 14

St Louis, Missouri, United States

Site Status

Glenmark Investigational Site 9

Englewood, Ohio, United States

Site Status

Glenmark Investigational Site7

Altoona, Pennsylvania, United States

Site Status

Glenmark Investigational Site 36

Knoxville, Tennessee, United States

Site Status

Glenmark Investigational Site 39

Nashville, Tennessee, United States

Site Status

Glenmark Investigational Site 23

Beaumont, Texas, United States

Site Status

Glenmark Investigational Site 20

Bryan, Texas, United States

Site Status

Glenmark Investigational Site 34

Dallas, Texas, United States

Site Status

Glenmark Investigational Site 35

Houston, Texas, United States

Site Status

Glenmark Investigational Site 44

Houston, Texas, United States

Site Status

Glenmark Investigational Site 4

Lampasas, Texas, United States

Site Status

Glenmark Investigational Site 29

San Antonio, Texas, United States

Site Status

Glenmark Investigational Site 6

San Antonio, Texas, United States

Site Status

Glenmark Investigational Site 16

Charlottesville, Virginia, United States

Site Status

Glenmark Investigational Site12

Midlothian, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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GLK-1402

Identifier Type: -

Identifier Source: org_study_id

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