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

Information source: Amneal Pharmaceuticals, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis

Intervention: Diclofenac Sodium Topical Gel, 1% (Drug); Voltaren Topical Gel, 1% (Drug); Vehicle Diclofenac Sodium Topical Gel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amneal Pharmaceuticals, LLC

Official(s) and/or principal investigator(s):
Prayag Shah, MD, Study Director, Affiliation: Amneal Pharmaceuticals, LLC

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: WOMAC Pain Score

Eligibility

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Goa Medical College, Goa 403716, India

Sunshine Hospitals, Secunderabad, Andhra Pradesh 500003, India

King George Hospital, Visakhapatnam, Andhra Pradesh 530002, India

King George Hospital, Visakhapatnam, Andra Pradesh 530002, India

B. J. Medical College & Hospital, Ahmedabad, Gujarat 380016, India

GMERS Medical College and Hospital, Ahmedabad, Gujarat 380061, India

Rathi Orthopedic and Research Centre, Ahmedabad, Gujarat 380 015, India

Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra, Junagadh, Gujarat 362 001, India

Centre For Knee Surgery, Vadodara, Gujarat 390007, India

Shree Giriraj Multispeciality Hospital, Rajkot, Gujurat 360007, India

St Johns Medical College, Bangalore, Karnataka 560034, India

K L E Societys Jawaharlal Nehry Medical College, Belgaum, Karnataka 590010, India

Mysore Medical College, Mysore, Karnataka 570001, India

Government Medical College, Calicut, Calicut, Kerala 673008, India

Psm Dept Ltmmc & Ltmg Hospital, Mumbai, Maharashtra 400022, India

Government Medical College, Nagpur, Maharashtra 440009, India

Jasleen Hospital, Nagpur, Maharashtra 440010, India

Lata Mangeshkar Hospital, Nagpur, Maharashtra 440019, India

Bj Medical College, Pune, Maharashtra 411001, India

Malpani Multispeciality Hospital, Jaipur, Rajasthan 302023, India

Apollo Speciality Hospitals, Madurai, Tamil Nadu 625020, India

King Georges Medical University, Lucknow, Uttar Pradesh 226003, India

M V Hospital and Research Centre, Lucknow, Uttar Pradesh 226 003, India

Additional Information

Starting date: April 2014
Last updated: June 23, 2015

Page last updated: August 23, 2015

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