Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee

NCT ID: NCT02121002

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-12-31

Brief Summary

To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diclofenac Sodium Topical Gel, 1%

Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks

Group Type: EXPERIMENTAL

Diclofenac Sodium Topical Gel, 1%

Intervention Type: DRUG

Opaque, white gel

Voltaren Topical Gel, 1%

Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks

Group Type: ACTIVE_COMPARATOR

Voltaren Topical Gel, 1%

Intervention Type: DRUG

Opaque, white gel

Vehicle Diclofenac Sodium Topical Gel

Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks

Group Type: PLACEBO_COMPARATOR

Vehicle Diclofenac Sodium Topical Gel

Intervention Type: DRUG

Opaque, white gel

Interventions

Diclofenac Sodium Topical Gel, 1%

Opaque, white gel

Intervention Type: DRUG

Voltaren Topical Gel, 1%

Opaque, white gel

Intervention Type: DRUG

Vehicle Diclofenac Sodium Topical Gel

Opaque, white gel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee.
• Had 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.
• After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee
• If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study
• Able to tolerate rescue medication with paracetamol/acetaminophen.

Exclusion Criteria

• Pregnant or lactating or planning to become pregnant during the study period.
• X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
• History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
• After discontinuing all pain medications for at least 7 days, has a baseline score of ≥20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization.
• History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia.
• History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
• History of gastrointestinal bleeding or peptic ulcer disease.
• Use of warfarin or other anticoagulant therapy within 30 days of study randomization.
• Elevated transaminases at screening.
• Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of study randomization.
• Concomitant use of corticosteroids or use within 30 days of study randomization.
• Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
• Known allergy to aspirin or nonsteroidal anti-inflammatory drug
• Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study.
• Receipt of any drug as part of a research study within 30 days prior to screening.
• Previous participation in this study.
• Any use between screening and baseline of a treatment or medication that may potentially confound study assessment that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs).
• Recent history of major knee injury or surgery.
• Known history of positive HIV

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sristek Clinical Research Solutions Limited

INDUSTRY

Sponsor Role: collaborator

Amneal Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prayag Shah, MD

Role: STUDY_DIRECTOR

Amneal Pharmaceuticals, LLC

Locations

Sunshine Hospitals

Secunderabad, Andhra Pradesh, India

King George Hospital

Visakhapatnam, Andhra Pradesh, India

Rathi Orthopedic and Research Centre

Ahmedabad, Gujarat, India

B. J. Medical College & Hospital

Ahmedabad, Gujarat, India

GMERS Medical College and Hospital

Ahmedabad, Gujarat, India

Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra

Jūnāgadh, Gujarat, India

Centre For Knee Surgery

Vadodara, Gujarat, India

Shree Giriraj Multispeciality Hospital

Rajkot, Gujurat, India

St Johns Medical College

Bangalore, Karnataka, India

K L E Societys Jawaharlal Nehry Medical College

Belagavi, Karnataka, India

Mysore Medical College

Mysore, Karnataka, India

Government Medical College, Calicut

Calicut, Kerala, India

Psm Dept Ltmmc & Ltmg Hospital

Mumbai, Maharashtra, India

Government Medical College

Nagpur, Maharashtra, India

Jasleen Hospital

Nagpur, Maharashtra, India

Lata Mangeshkar Hospital

Nagpur, Maharashtra, India

Bj Medical College

Pune, Maharashtra, India

Malpani Multispeciality Hospital

Jaipur, Rajasthan, India

Apollo Speciality Hospitals

Madurai, Tamil Nadu, India

M V Hospital and Research Centre

Lucknow, Uttar Pradesh, India

King Georges Medical University

Lucknow, Uttar Pradesh, India

Goa Medical College

Goa, , India

Countries

India

Other Identifiers

AM-DCG-001

Identifier Type: -

Identifier Source: org_study_id