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

NCT02121002 | Completed Phase 3 Results DMC

• 1 other identifier: AM-DCG-001
• Study Type: interventional
• Target: 1,176
• Locations: 1 country
• Sites: 22

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

Keywords

Knee

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to 4 Weeks in WOMAC Pain Score

  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

  Baseline and Week 4

Study Arms (3)

Diclofenac Sodium Topical Gel, 1%

EXPERIMENTAL

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

Drug: Diclofenac Sodium Topical Gel, 1%

Voltaren Topical Gel, 1%

ACTIVE COMPARATOR

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

Drug: Voltaren Topical Gel, 1%

Vehicle Diclofenac Sodium Topical Gel

PLACEBO COMPARATOR

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

Drug: Vehicle Diclofenac Sodium Topical Gel

Interventions

Diclofenac Sodium Topical Gel, 1% DRUG

Opaque, white gel

Diclofenac Sodium Topical Gel, 1%

Voltaren Topical Gel, 1% DRUG

Opaque, white gel

Voltaren Topical Gel, 1%

Vehicle Diclofenac Sodium Topical Gel DRUG

Opaque, white gel

Vehicle Diclofenac Sodium Topical Gel

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amneal Pharmaceuticals, LLC: lead
• Sristek Clinical Research Solutions Limited: collaborator

Study Sites (22)

Sunshine Hospitals

Secunderabad, Andhra Pradesh, 500003, India

Location

King George Hospital

Visakhapatnam, Andhra Pradesh, 530002, India

Location

Rathi Orthopedic and Research Centre

Ahmedabad, Gujarat, 380 015, India

Location

B. J. Medical College & Hospital

Ahmedabad, Gujarat, 380016, India

Location

GMERS Medical College and Hospital

Ahmedabad, Gujarat, 380061, India

Location

Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra

Jūnāgadh, Gujarat, 362 001, India

Location

Centre For Knee Surgery

Vadodara, Gujarat, 390007, India

Location

Shree Giriraj Multispeciality Hospital

Rajkot, Gujurat, 360007, India

Location

St Johns Medical College

Bangalore, Karnataka, 560034, India

Location

K L E Societys Jawaharlal Nehry Medical College

Belagavi, Karnataka, 590010, India

Location

Mysore Medical College

Mysore, Karnataka, 570001, India

Location

Government Medical College, Calicut

Calicut, Kerala, 673008, India

Location

Psm Dept Ltmmc & Ltmg Hospital

Mumbai, Maharashtra, 400022, India

Location

Government Medical College

Nagpur, Maharashtra, 440009, India

Location

Jasleen Hospital

Nagpur, Maharashtra, 440010, India

Location

Lata Mangeshkar Hospital

Nagpur, Maharashtra, 440019, India

Location

Bj Medical College

Pune, Maharashtra, 411001, India

Location

Malpani Multispeciality Hospital

Jaipur, Rajasthan, 302023, India

Location

Apollo Speciality Hospitals

Madurai, Tamil Nadu, 625020, India

Location

M V Hospital and Research Centre

Lucknow, Uttar Pradesh, 226 003, India

Location

King Georges Medical University

Lucknow, Uttar Pradesh, 226003, India

Location

Goa Medical College

Goa, 403716, India

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Candis Edwards
• Organization: Amneal Pharmaceuticals

cedwards@amneal.com

631-974-7949

Study Officials

• Prayag Shah, MD

  Amneal Pharmaceuticals, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 23, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 16, 2021
• Results First Posted: June 16, 2021

Record last verified: 2021-05

Locations

IN (22)