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

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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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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
Egalet

5 total trials

What the finished NCT02716857 record still lists

NCT02716857 is an interventional study that assigns participants to a tested intervention. The registered 549 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower).

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 names 20 study sites across 5 states, led by 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.

How this trial's enrollment target compares

Where NCT02716857's enrollment target sits among peer trials

549 689th of 2000 higher than 1,312 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT02716857, the US trial registry maintained by the National Library of Medicine. NCT02716857 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.