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

Osteoarthritis Clinical Trial

Official title:

A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121002
• Other study ID #: AM-DCG-001
• Status: Completed
• Phase: Phase 3
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2021
• Source: Amneal Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1176
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Diclofenac Sodium Topical Gel, 1%
Opaque, white gel
• Voltaren Topical Gel, 1%
Opaque, white gel
• Vehicle Diclofenac Sodium Topical Gel
Opaque, white gel

Locations

Country	Name	City	State
India	B. J. Medical College & Hospital	Ahmedabad	Gujarat
India	GMERS Medical College and Hospital	Ahmedabad	Gujarat
India	Rathi Orthopedic and Research Centre	Ahmedabad	Gujarat
India	St Johns Medical College	Bangalore	Karnataka
India	K L E Societys Jawaharlal Nehry Medical College	Belgaum	Karnataka
India	Government Medical College, Calicut	Calicut	Kerala
India	Goa Medical College	Goa
India	Malpani Multispeciality Hospital	Jaipur	Rajasthan
India	Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra	Junagadh	Gujarat
India	King Georges Medical University	Lucknow	Uttar Pradesh
India	M V Hospital and Research Centre	Lucknow	Uttar Pradesh
India	Apollo Speciality Hospitals	Madurai	Tamil Nadu
India	Psm Dept Ltmmc & Ltmg Hospital	Mumbai	Maharashtra
India	Mysore Medical College	Mysore	Karnataka
India	Government Medical College	Nagpur	Maharashtra
India	Jasleen Hospital	Nagpur	Maharashtra
India	Lata Mangeshkar Hospital	Nagpur	Maharashtra
India	Bj Medical College	Pune	Maharashtra
India	Shree Giriraj Multispeciality Hospital	Rajkot	Gujurat
India	Sunshine Hospitals	Secunderabad	Andhra Pradesh
India	Centre For Knee Surgery	Vadodara	Gujarat
India	King George Hospital	Visakhapatnam	Andhra Pradesh
India	King George Hospital	Visakhapatnam	Andra Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
Amneal Pharmaceuticals, LLC	Sristek Clinical Research Solutions Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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