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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT02716857

Public ClinicalTrials.gov record NCT02716857. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 3:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Egalet® Abuse-deterrent, Extended-release (ADER) Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Low Back Pain

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT02716857
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Egalet Ltd
Industry
Enrollment
549 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2016 (Type not available)
Primary completion
Aug 2017 (Actual)
Completion
Nov 2017 (Actual)
Last update posted
Mar 5, 2018

2016 – 2017

United States locations

U.S. sites
74
U.S. states
28
U.S. cities
68
Facility City State ZIP Site status
Site 207 Birmingham Alabama 35209 —
Site 202 Mobile Alabama 36608 —
Site 253 Phoenix Arizona 85018 —
Site 260 Phoenix Arizona 85018 —
Site 268 Phoenix Arizona 85029 —
Site 282 Tucson Arizona 85704 —
Site 217 Anaheim California 92801 —
Site 280 Anaheim California 92804 —
Site 220 La Mesa California 91942 —
Site 235 Laguna Hills California 92637 —
Site 215 Long Beach California 90806 —
Site 238 Los Gatos California 95032 —
Site 262 Napa California 94558 —
Site 201 Oakland California 94607 —
Site 225 Sacramento California 95831 —
Site 231 San Diego California 92105 —
Site 237 San Diego California 92120 —
Site 221 Wildomar California 92595 —
Site 248 Boulder Colorado 80301 —
Site 228 Bradenton Florida 34205 —
Site 214 Clearwater Florida 33765 —
Site 270 Gainesville Florida 32607 —
Site 269 Inverness Florida 34452 —
Site 227 Jupiter Florida 33458 —
SIte 204 Lake Worth Florida 33462 —
Site 211 Miami Beach Florida 33140 —
Site 229 Miami Beach Florida 33140 —
Site 278 Plantation Florida 33317 —
Site 232 Port Orange Florida 32129 —
Site 264 Sarasota Florida 34232 —
Site 271 Winter Park Florida 32789 —
Site 223 Atlanta Georgia 30309 —
Site 212 Marietta Georgia 30060 —
Site 245 Boise Idaho 83713 —
Site 255 Chicago Illinois 60614 —
Site 222 Evansville Indiana 47714 —
SIte 236 West Des Moines Iowa 50265 —
Site 277 Overland Park Kansas 66210 —
Site 206 New Orleans Louisiana 70115 —
Site 224 Shreveport Louisiana 71105 —
Site 249 Pikesville Maryland 21208 —
Site 226 Boston Massachusetts 02135 —
Site 254 New Bedford Massachusetts 02740 —
Site 210 Bay City Michigan 48706 —
Site 244 Jackson Mississippi 39202 —
Site 234 Hazelwood Missouri 63042 —
Site 265 Omaha Nebraska 68114 —
Site 266 Princeton New Jersey 08540 —
Site 267 Somerset New Jersey 08873 —
Site 252 Albuquerque New Mexico 87102 —
Site 261 Kew Gardens New York 11415 —
Site 243 New York New York 10019 —
Site 233 Rochester New York 14618 —
Site 208 Williamsville New York 14221 —
Site 203 Charlotte North Carolina 28209 —
Site 213 Winston-Salem North Carolina 27103 —
Site 242 Winston-Salem North Carolina 27103 —
Site 276 Columbus Ohio 43210 —
Site 209 Franklin Ohio 45005 —
Site 259 Kettering Ohio 45429 —
Site 240 Toledo Ohio 43623 —
Site 239 Oklahoma City Oklahoma 73119 —
Site 279 Duncansville Pennsylvania 16635 —
Site 256 Jenkintown Pennsylvania 19046 —
Site 258 Lansdale Pennsylvania 19446 —
Site 205 Charleston South Carolina 29406 —
Site 247 Greenville South Carolina 29601 —
Site 251 Spartanburg South Carolina 29303 —
Site 218 Austin Texas 78704 —
Site 263 Hurst Texas 76054 —
Site 219 Richardson Texas 75080 —
Site 275 San Antonio Texas 78207 —
Site 241 Everett Washington 98201 —
Site 257 Spokane Washington 99202 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02716857, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 5, 2018 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02716857 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →