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Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%

NCT01456611 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 749

Last updated 2012-07-12

No results posted yet for this study

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.

Conditions

  • Osteo Arthritis of the Knee

Interventions

DRUG

Diclofenac

Diclofenac Sodium Gel 1%

DRUG

Placebo

Placebo Topical Gel

Sponsors & Collaborators

  • Novum Pharmaceutical Research Services

    collaborator INDUSTRY

  • Anchen Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

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 NCT01456611 on ClinicalTrials.gov