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



Status:Completed
Healthy:No
Age Range:18 - 75
Updated:4/17/2018
Start Date:March 7, 2016
End Date:June 15, 2017

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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

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.


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
We found this trial at
39
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Duncansville, Pennsylvania 16635
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Mooresville, North Carolina 28117
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Myrtle Beach, South Carolina 29572
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Summerville, South Carolina 29485
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