A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium 1% Gel (Anchen Pharmaceuticals, Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee

Anchen Pharmaceuticals, Inc1 site in 1 country749 target enrollmentSeptember 2011

ConditionsOsteo Arthritis of the Knee

InterventionsDiclofenac Placebo

DrugsDiclofenac Placebo

Overview

Phase: Phase 3
Intervention: Diclofenac
Conditions: Osteo Arthritis of the Knee
Sponsor: Anchen Pharmaceuticals, Inc
Enrollment: 749
Locations: 1
Primary Endpoint: Mean Change from Baseline in WOMAC Pain Scale
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to the marketed formulation Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in patients with osteoarthritis of the knee.

The efficacy of both the Test and Reference formulations will also be compared to the Placebo gel to determine Superiority.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

April 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Anchen Pharmaceuticals, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ambulatory Male and Non Pregnant Females 35 years and older diagnosed with osteoarthritis (according to the American College of Rheumatology Criteria) in one or both knees.
•ACR Criteria includes, Knee Pain and at least 3 of the following:
•stiffness lasting \< 30 mins
•bony tenderness
•bony enlargement
•no palpable warmth
•Symptom onset of \> 6 Months prior to Screening for the target knee.
•If female and of child-bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom + spermicide, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
•Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc) requiring the use of oral or topical treatments (NSAIDS or acetaminophen) for \> 15 days in the 30 days prior to Screening.
•Radiograph of the target knee within the previous year with a Grade 1, 2 or 3 disease based upon the Kellgren-Lawrence disease severity scale.

Exclusion Criteria

•Females who are pregnant, breast feeding, or planning a pregnancy
•Radiograph of the target knee within the previous year with a Grade 4 score on the Kellgren-Lawrence disease severity scale. 24
•History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
•After a 7 day wash out of all pain medication has baseline pain on movement score of ≥ 20mm on a 100-mm Visual Analogue Scale for the contralateral knee immediately prior to randomization.
•Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) or rheumatoid arthritis.
•Known history of other chronic inflammatory diseases, (e.g.,colitis) or fibromyalgia.
•History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
•History of coronary artery bypass graft within 6 months of screening.
•Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max 162mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
•Use of warfarin or other anticoagulant therapy within 30 days of screening.