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NCT02596451 · ClinicalTrials.gov registry record · Phase 3

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).

A Phase 3 study of Osteoarthritis, sponsored by Glenmark Pharmaceuticals Ltd. India.

Completed
Registry status
Phase 3
Development phase
1,164
Enrollment target
20
Study locations

NCT02596451: Completed Phase 3 study of Osteoarthritis, sponsored by Glenmark Pharmaceuticals Ltd. India.

NCT02596451 is a Phase 3 study of Osteoarthritis that has completed, run by Glenmark Pharmaceuticals Ltd. India. The registered enrollment target is 1,164 participants, above the 809-participant average among 135 other Osteoarthritis trials with a reported enrollment target (44% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02596451, a Phase 3 study of Osteoarthritis, has completed, sponsored by Glenmark Pharmaceuticals Ltd. India.

COMPLETED
Registry status
Phase 3
Development phase
1,164 participants
Enrollment target
20
Study locations

Study Summary

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

Primary Outcome

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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Diclofenac Sodium gel, 1%
  • DRUG Voltaren® Gel

Study Locations (20)

California

  • Glenmark Investigational Site 1 - Anaheim
  • Glenmark Investigational Site 21 - Anaheim
  • Glenmark Investigational Site 31 - Anaheim
  • Glenmark Investigational Site 26 - Canoga Park
  • Glenmark Investigational Site 42 - Carlsbad
  • Glenmark Investigational Site 30 - Carmichael
  • Glenmark Investigational Site 33 - Cerritos
  • Glenmark Investigational Site 25 - El Cajon
  • Glenmark Investigational Site 24 - La Mesa
  • Glenmark Investigational Site 2 - Pasadena
  • Glenmark Investigational Site 13 - Rancho Cucamonga
  • Glenmark Investigational Site 27 - Sacramento

Florida

  • Glenmark Investigational Site 10 - Fort Lauderdale
  • Glenmark Investigational Site 41 - Hialeah
  • Glenmark Investigational Site 15 - Miami
  • Glenmark Investigational Site 19 - Miami
  • Glenmark Investigational Site 28 - Miami
  • Glenmark Investigational Site 32 - Miami
  • Glenmark Investigational Site 40 - Miami

Arizona

  • Glenmark Investigational Site 5 - Mesa

Trial Details

FieldValue
Enrollment Target 1,164 participants
Start Date 2015-08
Est. Completion 2016-03
Phase Phase 3

What the finished NCT02596451 record still lists

NCT02596451 is an interventional study that assigns participants to a tested intervention. Its 1,164 participants enrollment target places it among the larger protocols in the corpus, above the 809-participant average among 135 other Osteoarthritis trials with a reported enrollment target (44% higher).

The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT02596451 names 20 study sites across 3 states, led by California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT02596451 about?

NCT02596451 is a clinical study titled "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).". 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 wi...

What is the current status of trial NCT02596451?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,164 participants. The study started on 2015-08. Estimated completion is 2016-03.

What conditions does trial NCT02596451 study?

This clinical trial studies the following conditions: Osteoarthritis.

What interventions are being tested in trial NCT02596451?

The interventions under investigation include: Placebo (DRUG), Diclofenac Sodium gel, 1% (DRUG), Voltaren® Gel (DRUG).

Who is sponsoring clinical trial NCT02596451?

This trial is sponsored by Glenmark Pharmaceuticals Ltd. India, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02596451 being conducted?

This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Osteoarthritis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02596451's enrollment target sits among peer trials

1,164 12th of 135 higher than 124 of 135 other Osteoarthritis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02596451, the US trial registry maintained by the National Library of Medicine. NCT02596451 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.