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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.
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 549 participants |
| Start Date | 2016-03 |
| Est. Completion | 2017-11 |
| Phase | Phase 3 |
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.
Learn More About Clinical Trials
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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