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Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%

NCT02913521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 934

Last updated 2021-02-26

Study results available
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Summary

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Diclofenac Sodium Gel 1%

DRUG

Voltaren Gel

DRUG

Placebo

Sponsors & Collaborators

  • Akorn, Inc.

    lead INDUSTRY

Principal Investigators

  • Kalev Kask, Ph.D. · EGeen International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-04-30
Completion
2016-06-30

Countries

  • Estonia
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02913521 on ClinicalTrials.gov