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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Voltaren Topical Gel, 1%; Drug: Vehicle Diclofenac Sodium Topical Gel; Drug: Diclofenac Sodium Topical Gel, 1%

• Registration Number: NCT02121002
• Lead Sponsor: Amneal Pharmaceuticals, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-04-21
• Study First Posted: 2014-04-23
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Disposition First Submitted: 2015-06-23
• Disposition First Submitted QC: 2015-06-23
• Disposition First Posted: 2015-07-16
• Results First Submitted: 2021-04-30
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-21
• Last Update Submitted: 2021-05-21
• Results First Posted: 2021-06-16
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1176

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Voltaren Topical Gel, 1%	Voltaren Topical Gel, 1%	Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Vehicle Diclofenac Sodium Topical Gel	Vehicle Diclofenac Sodium Topical Gel	Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks
Diclofenac Sodium Topical Gel, 1%	Diclofenac Sodium Topical Gel, 1%	Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline to 4 Weeks in WOMAC Pain Score	Baseline and Week 4	Mean change from baseline to week 4 in the Western Ontario McMaster; Osteoarthritis (WOMAC) pain score: 5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4

Trial Locations

Locations (22)

Shree Giriraj Multispeciality Hospital; 🇮🇳 Rajkot, Gujurat, India

Rathi Orthopedic and Research Centre; 🇮🇳 Ahmedabad, Gujarat, India

Sunshine Hospitals; 🇮🇳 Secunderabad, Andhra Pradesh, India

King George Hospital; 🇮🇳 Visakhapatnam, Andra Pradesh, India

Psm Dept Ltmmc & Ltmg Hospital; 🇮🇳 Mumbai, Maharashtra, India

Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra; 🇮🇳 Junagadh, Gujarat, India

St Johns Medical College; 🇮🇳 Bangalore, Karnataka, India

Goa Medical College; 🇮🇳 Goa, India

Government Medical College; 🇮🇳 Nagpur, Maharashtra, India

Jasleen Hospital; 🇮🇳 Nagpur, Maharashtra, India

Mysore Medical College; 🇮🇳 Mysore, Karnataka, India

Bj Medical College; 🇮🇳 Pune, Maharashtra, India

K L E Societys Jawaharlal Nehry Medical College; 🇮🇳 Belgaum, Karnataka, India

Government Medical College, Calicut; 🇮🇳 Calicut, Kerala, India

King Georges Medical University; 🇮🇳 Lucknow, Uttar Pradesh, India

GMERS Medical College and Hospital; 🇮🇳 Ahmedabad, Gujarat, India

Apollo Speciality Hospitals; 🇮🇳 Madurai, Tamil Nadu, India

B. J. Medical College & Hospital; 🇮🇳 Ahmedabad, Gujarat, India

Centre For Knee Surgery; 🇮🇳 Vadodara, Gujarat, India

Lata Mangeshkar Hospital; 🇮🇳 Nagpur, Maharashtra, India

Malpani Multispeciality Hospital; 🇮🇳 Jaipur, Rajasthan, India

M V Hospital and Research Centre; 🇮🇳 Lucknow, Uttar Pradesh, India