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Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1% | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%

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

NCT01456611•Anchen Pharmaceuticals, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

35 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. 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:
•1. age ≥ 50
•2. stiffness lasting \< 30 mins
•3. bony tenderness
•4. crepitus
•5. bony enlargement
•6. no palpable warmth
•2\. Symptom onset of \> 6 Months prior to Screening for the target knee.
•3\. 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).
+6 more criteria

Exclusion Criteria

•1. Females who are pregnant, breast feeding, or planning a pregnancy
•2. Radiograph of the target knee within the previous year with a Grade 4 score on the Kellgren-Lawrence disease severity scale. 24
•3. History of osteoarthritis in the contralateral knee requiring medication (OTC or prescription) within 12 months of screening.
•4. 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.
•5. Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty arthritis) or rheumatoid arthritis.
•6. Known history of other chronic inflammatory diseases, (e.g.,colitis) or fibromyalgia.
•7. History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
•8. History of coronary artery bypass graft within 6 months of screening.
•9. 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.
•10. Use of warfarin or other anticoagulant therapy within 30 days of screening.
+9 more criteria

Locations (57)

Novum Investigator Site

Birmingham, Alabama, United States

Novum Investigator Site

Huntsville, Alabama, United States

Novum Investigator Site

Chandler, Arizona, United States

Novum Investigator Site

Mesa, Arizona, United States

Novum Investigator Site

Phoenix, Arizona, United States

Novum Investigator Site

Tuscon, Arizona, United States

Novum Investigator Site

Little Rock, Arkansas, United States

Novum Investigator Site

Anaheim, California, United States

Novum Investigator Site

Carmichael, California, United States

Novum Investigator Site

Garden Grove, California, United States

Key Dates

Start Date

September 1, 2011

Primary Completion Date

April 1, 2012

Completion Date

April 1, 2012

Last Updated

July 12, 2012

Enrollment

749

ACTUAL participants

Conditions

Osteo Arthritis of the Knee

Interventions

Diclofenac

DRUG

Placebo

DRUG

Dinalbuphine Sebacate in Postoperative Pain Control After TKA

NCT07140510

Osteo Arthritis of the KneeTotal Knee Anthroplasty

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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