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

NCT02716857 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 549

Last updated 2018-03-05

No results posted yet for this 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

  • Moderate-to-severe Chronic Low Back Pain

Interventions

DRUG

Oxycodone extended-release

DRUG

Placebo of oxycodone extended-release

Sponsors & Collaborators

  • Egalet Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-08-31
Completion
2017-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02716857 on ClinicalTrials.gov