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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 Sep 5, 2026, 5:32 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
Feb 29, 2016
Primary completion
Jul 31, 2017
Completion
Oct 31, 2017
Last update posted
Mar 4, 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 4, 2018 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02716857 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →