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Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain

CompletedPhase 3NCT02603705
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of this study is to evaluate the safety and tolerability of Egalet-002 in opioid-experienced patients with moderate-to-severe chronic noncancer pain.

Study details

Official title
An Open-label Phase 3 Trial to Evaluate the Safety and Tolerability of Egalet ADER Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Noncancer Pain
Conditions
  • Moderate-to-severe Chronic Noncancer Pain
Interventions
  • Drug: Oxycodone extended-release
Sponsor
Egalet Ltd
Start date
2016-03-07
Primary completion
2017-06-15
Sex
All
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
39

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Is a man or woman between 18 and 75 years of age. * Has a clinical history of moderate-to-severe chronic noncancer pain ≥6 months. * Has required opioid therapy for at least 14 days prior to Screening at a dose between 20 mg and 160 mg (inclusive) oxycodone/day (or opioid equivalent), and will, in the opinion of the investigator, continue to require opioid therapy (between 20 mg and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe pain for the duration of the study. * Has pain either not adequately controlled on current opioid regimen, requires a change of opioid due to tolerability of current opioid regimen or in the opinion of the investigator, would benefit from changing opioid for another reason. * Has stable health, as determined by the investigator. * If female, the patient is currently not pregnant, not breast-feeding, nor attempting to become pregnant (for 30 days before screening through the duration of the study), or is of non-childbearing potential. * Other Criteria Apply Exclusion Criteria: * Has cancer-related pain. * Is receiving \>240 mg oxycodone daily (or opioid equivalent) within 30 days before Screening. * Has a history of attempted suicide. * Has used a spinal infusion pump within 6 months before Screening. * Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia) and/or respiratory disease (including chronic obstructive pulmonary disease or sleep apnea). * Has positive urine toxicity screen for drugs of abuse (with the exception of prescribed medications). * Has positive result for tetrahydrocannabinol (even if legally prescribed). * Has current (or history of within the last 12 months) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine). * Other Criteria Apply

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02603705