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COMPLETED Phase 3

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

NCT02716857 · View on ClinicalTrials.gov ↗

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

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02716857

The ClinicalTrials.gov registry entry for NCT02716857 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02716857 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02716857?

The interventions under investigation include: Oxycodone extended-release (DRUG), Placebo of oxycodone extended-release (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02716857?

This trial is sponsored by Egalet, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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