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NCT02716857 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain

A Phase 3 study of Moderate-to-severe Chronic Low Back Pain, sponsored by Egalet.

Completed
Registry status
Phase 3
Development phase
549
Enrollment target
20
Study locations

NCT02716857 is a Phase 3 study of Moderate-to-severe Chronic Low Back Pain that has completed, run by Egalet. The registered enrollment target is 549 participants. The trial reports 20 study locations across 5 states.

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The verdict

NCT02716857, a Phase 3 study of Moderate-to-severe Chronic Low Back Pain, has completed, sponsored by Egalet.

COMPLETED
Registry status
Phase 3
Development phase
549 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine the analgesic efficacy of Egalet-002 twice daily (BID) in patients with moderate-to-severe chronic low back pain

Interventions

  • DRUG Oxycodone extended-release
  • DRUG Placebo of oxycodone extended-release

Study Locations (20)

California

  • Site 217 - Anaheim
  • Site 280 - Anaheim
  • Site 220 - La Mesa
  • Site 235 - Laguna Hills
  • Site 215 - Long Beach
  • Site 238 - Los Gatos
  • Site 262 - Napa
  • Site 201 - Oakland
  • Site 225 - Sacramento
  • Site 231 - San Diego
  • Site 237 - San Diego
  • Site 221 - Wildomar

Arizona

  • Site 253 - Phoenix
  • Site 260 - Phoenix
  • Site 268 - Phoenix
  • Site 282 - Tucson

Alabama

  • Site 207 - Birmingham
  • Site 202 - Mobile

Colorado

  • Site 248 - Boulder

Florida

  • Site 228 - Bradenton

Trial Details

FieldValue
Enrollment Target 549 participants
Start Date 2016-03
Est. Completion 2017-11
Phase Phase 3

Sponsor

Egalet

5 total trials

What the Registry Record Tells You About NCT02716857

The ClinicalTrials.gov registry entry for NCT02716857 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 549 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Egalet, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Moderate-to-severe Chronic Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Oxycodone extended-release is the first listed.

NCT02716857 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT02716857 about?

NCT02716857 is a clinical study titled "Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain". The purpose of this study is to determine the analgesic efficacy of Egalet-002 twice daily (BID) in patients with moderate-to-severe chronic low back pain

What is the current status of trial NCT02716857?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 549 participants. The study started on 2016-03. Estimated completion is 2017-11.

What conditions does trial NCT02716857 study?

This clinical trial studies the following conditions: Moderate-to-severe Chronic Low Back Pain.

What interventions are being tested in trial NCT02716857?

The interventions under investigation include: Oxycodone extended-release (DRUG), Placebo of oxycodone extended-release (DRUG).

Who is sponsoring clinical trial NCT02716857?

This trial is sponsored by Egalet, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02716857 being conducted?

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

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.