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NCT02116972 · ClinicalTrials.gov registry record · Phase 2

Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

A Phase 2 study of Osteoarthritis of the Knee, sponsored by Pacira Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
310
Enrollment target
20
Study locations

NCT02116972 is a Phase 2 study of Osteoarthritis of the Knee that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 310 participants, above the 201-participant average among 15 other Osteoarthritis of the Knee trials with a reported enrollment target (54% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT02116972, a Phase 2 study of Osteoarthritis of the Knee, has completed, sponsored by Pacira Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
310 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).

Conditions Studied

Osteoarthritis of the Knee

Interventions

  • DRUG Placebo
  • DRUG FX006 32 mg
  • DRUG FX006 16 mg

Study Locations (20)

California

  • - Anaheim
  • - Canoga Park
  • - El Cajon
  • - Los Angeles
  • - North Hollywood
  • - San Diego

Florida

  • - DeLand
  • - Fort Lauderdale
  • - Orlando
  • - Pinellas Park
  • - Tampa

Alabama

  • - Anniston
  • - Birmingham
  • - Mobile

Arizona

  • - Phoenix
  • - Tucson

Arkansas

  • - Hot Springs

Connecticut

  • - Stamford

Georgia

  • - Marietta

Indiana

  • - Evansville

Trial Details

FieldValue
Enrollment Target 310 participants
Start Date 2014-04
Est. Completion 2015-11
Phase Phase 2

Sponsor

Pacira Pharmaceuticals

88 total trials

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What the Registry Record Tells You About NCT02116972

The ClinicalTrials.gov registry entry for NCT02116972 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 201-participant average among 15 other Osteoarthritis of the Knee trials with a reported enrollment target (54% higher). The listed sponsor is Pacira Pharmaceuticals, which has 88 total studies on file at ClinicalTrials.gov.

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

NCT02116972 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT02116972 about?

NCT02116972 is a clinical study titled "Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee". The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).

What is the current status of trial NCT02116972?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 310 participants. The study started on 2014-04. Estimated completion is 2015-11.

What conditions does trial NCT02116972 study?

This clinical trial studies the following conditions: Osteoarthritis of the Knee.

What interventions are being tested in trial NCT02116972?

The interventions under investigation include: Placebo (DRUG), FX006 32 mg (DRUG), FX006 16 mg (DRUG).

Who is sponsoring clinical trial NCT02116972?

This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02116972 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.