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

May 21, 2021 updated by: Amneal Pharmaceuticals, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Goa, India, 403716
        • Goa Medical College
    • Andhra Pradesh
      • Secunderabad, Andhra Pradesh, India, 500003
        • Sunshine Hospitals
      • Visakhapatnam, Andhra Pradesh, India, 530002
        • King George Hospital
    • Andra Pradesh
      • Visakhapatnam, Andra Pradesh, India, 530002
        • King George Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 015
        • Rathi Orthopedic and Research Centre
      • Ahmedabad, Gujarat, India, 380016
        • B. J. Medical College & Hospital
      • Ahmedabad, Gujarat, India, 380061
        • GMERS Medical College and Hospital
      • Junagadh, Gujarat, India, 362 001
        • Shir Hatkesh Sarvajanik Tabibi Chikitsha Kendra
      • Vadodara, Gujarat, India, 390007
        • Centre For Knee Surgery
    • Gujurat
      • Rajkot, Gujurat, India, 360007
        • Shree Giriraj Multispeciality Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • St Johns Medical College
      • Belgaum, Karnataka, India, 590010
        • K L E Societys Jawaharlal Nehry Medical College
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College
    • Kerala
      • Calicut, Kerala, India, 673008
        • Government Medical College, Calicut
    • Maharashtra
      • Mumbai, Maharashtra, India, 400022
        • Psm Dept Ltmmc & Ltmg Hospital
      • Nagpur, Maharashtra, India, 440009
        • Government Medical College
      • Nagpur, Maharashtra, India, 440010
        • Jasleen Hospital
      • Nagpur, Maharashtra, India, 440019
        • Lata Mangeshkar Hospital
      • Pune, Maharashtra, India, 411001
        • BJ Medical College
    • Rajasthan
      • Jaipur, Rajasthan, India, 302023
        • Malpani Multispeciality Hospital
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625020
        • Apollo Speciality Hospitals
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226 003
        • M V Hospital and Research Centre
      • Lucknow, Uttar Pradesh, India, 226003
        • King Georges Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Diclofenac Sodium Topical Gel, 1%
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Drug: Diclofenac Sodium Topical Gel, 1%
Opaque, white gel
Active Comparator: Voltaren Topical Gel, 1%
Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Drug: Voltaren Topical Gel, 1%
Opaque, white gel
Placebo Comparator: Vehicle Diclofenac Sodium Topical Gel
Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks
Drug: Vehicle Diclofenac Sodium Topical Gel
Opaque, white gel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to 4 Weeks in WOMAC Pain Score
Time Frame: Baseline and Week 4

Mean change from baseline to week 4 in the Western Ontario McMaster

Osteoarthritis (WOMAC) pain score:

5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amneal Pharmaceuticals, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sristek Clinical Research Solutions Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Prayag Shah, MD, Amneal Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AM-DCG-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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