To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).

May 26, 2017 updated by: Glenmark Pharmaceuticals Ltd. India

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc) in Patients With Osteoarthritis (OA) of the Knee

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) 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.
1164

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

  • United States
    • Arizona
      • Mesa, Arizona, United States
        • Glenmark Investigational Site 5
    • California
      • Anaheim, California, United States
        • Glenmark Investigational Site 31
      • Anaheim, California, United States
        • Glenmark Investigational Site 1
      • Anaheim, California, United States
        • Glenmark Investigational Site 21
      • Canoga Park, California, United States
        • Glenmark Investigational Site 26
      • Carlsbad, California, United States
        • Glenmark Investigational Site 42
      • Carmichael, California, United States
        • Glenmark Investigational Site 30
      • Cerritos, California, United States
        • Glenmark Investigational Site 33
      • El Cajon, California, United States
        • Glenmark Investigational Site 25
      • La Mesa, California, United States
        • Glenmark Investigational Site 24
      • Pasadena, California, United States
        • Glenmark Investigational Site 2
      • Rancho Cucamonga, California, United States
        • Glenmark Investigational Site 13
      • Sacramento, California, United States
        • Glenmark Investigational Site 27
    • Florida
      • Fort Lauderdale, Florida, United States
        • Glenmark Investigational Site 10
      • Hialeah, Florida, United States
        • Glenmark Investigational Site 41
      • Miami, Florida, United States
        • Glenmark Investigational Site 19
      • Miami, Florida, United States
        • Glenmark Investigational Site 40
      • Miami, Florida, United States
        • Glenmark Investigational Site 15
      • Miami, Florida, United States
        • Glenmark Investigational Site 28
      • Miami, Florida, United States
        • Glenmark Investigational Site 32
      • Miami Lakes, Florida, United States
        • Glenmark Investigational Site 3
      • Ormond Beach, Florida, United States
        • Glenmark Investigational Site 37
      • West Palm Beach, Florida, United States
        • Glenmark Investigational Site 11
      • West Palm Beach, Florida, United States
        • Glenmark Investigational Site 18
    • Illinois
      • Evanston, Illinois, United States
        • Glenmark Investigational Site 8
    • Indiana
      • Newburgh, Indiana, United States
        • Glenmark Investigational Site 43
    • Kansas
      • Wichita, Kansas, United States
        • Glenmark Investigational Site 38
    • Louisiana
      • New Orleans, Louisiana, United States
        • Glenmark Investigational Site 17
    • Michigan
      • Saginaw, Michigan, United States
        • Glenmark Investigational Site 22
    • Missouri
      • Saint Louis, Missouri, United States
        • Glenmark Investigational Site 14
    • Ohio
      • Englewood, Ohio, United States
        • Glenmark Investigational Site 9
    • Pennsylvania
      • Altoona, Pennsylvania, United States
        • Glenmark Investigational Site7
    • Tennessee
      • Knoxville, Tennessee, United States
        • Glenmark Investigational Site 36
      • Nashville, Tennessee, United States
        • Glenmark Investigational Site 39
    • Texas
      • Beaumont, Texas, United States
        • Glenmark Investigational Site 23
      • Bryan, Texas, United States
        • Glenmark Investigational Site 20
      • Dallas, Texas, United States
        • Glenmark Investigational Site 34
      • Houston, Texas, United States
        • Glenmark Investigational Site 35
      • Houston, Texas, United States
        • Glenmark Investigational Site 44
      • Lampasas, Texas, United States
        • Glenmark Investigational Site 4
      • San Antonio, Texas, United States
        • Glenmark Investigational Site 29
      • San Antonio, Texas, United States
        • Glenmark Investigational Site 6
    • Virginia
      • Charlottesville, Virginia, United States
        • Glenmark Investigational Site 16
      • Midlothian, Virginia, United States
        • Glenmark Investigational Site12

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:

  1. Healthy male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria.
  2. OA Symptoms for at least 6 months prior to screening.
  3. Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of > 9 on a 20 point scale for the target knee immediately prior to randomization.

Exclusion Criteria:

  1. History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
  2. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
  3. History of gastrointestinal bleeding or peptic ulcer disease.
  4. Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
  5. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.
  6. Concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.

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: Triple

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 gel, 1%
apply gel to the target knee
Drug: Diclofenac Sodium gel, 1%
Active Comparator: Voltaren® Gel
apply gel to the target knee
Drug: Voltaren® Gel
Placebo Comparator: Placebo
apply gel to the target knee
Drug: Placebo

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
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
Time Frame: Baseline and week 4
The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.
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.
Glenmark Pharmaceuticals Ltd. India

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: Mahesh V Deshpande, Glenmark Pharmaceuticals Ltd

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.
August 1, 2015

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.
March 1, 2016

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.
March 1, 2016

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).
November 3, 2015

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.
November 3, 2015

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.
November 4, 2015

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 28, 2017

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 26, 2017

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.
July 1, 2016

More Information

Terms related to this study

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.
  • GLK-1402

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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