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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02603705
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moderate-to-severe Chronic Noncancer Pain Drug: Oxycodone extended-release Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 7, 2016
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : June 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxycodone extended-release
Egalet abuse-deterrent, extended-release oxycodone tablet
Drug: Oxycodone extended-release



Primary Outcome Measures :
  1. Incidence of TEAEs during the Open-label Treatment Period, including those leading to treatment withdrawal, and/or abnormal physical examination findings, vital signs measurements, ECGs, and clinical laboratory test results, related to treatment [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603705


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Sponsors and Collaborators
Egalet Ltd

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Responsible Party: Egalet Ltd
ClinicalTrials.gov Identifier: NCT02603705     History of Changes
Other Study ID Numbers: OC-EG-303
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Keywords provided by Egalet Ltd:
chronic pain
opioid
oxycodone
non cancer pain
moderate to severe

Additional relevant MeSH terms:
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Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents