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

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ClinicalTrials.gov Identifier: NCT02716857
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Moderate-to-severe Chronic Low Back Pain Drug: Oxycodone extended-release Drug: Placebo of oxycodone extended-release Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 549 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Oxycodone extended-release
Egalet ADER oxycodone tablet
Drug: Oxycodone extended-release
Other Name: Egalet-002, Egalet ADER oxycodone

Placebo Comparator: Placebo of Oxycodone extended-release
Egalet ADER oxycodone placebo tablet
Drug: Placebo of oxycodone extended-release



Primary Outcome Measures :
  1. Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime. [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Efficacy: daily (past 24 hours) worst pain intensity score (WPI) [ Time Frame: 16 Weeks ]
  2. Safety: Incidence of TEAEs, 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: 16 weeks ]


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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 an English-speaking man or woman between 18 and 75 years of age who has given written informed consent.
  • Has a clinical diagnosis of moderate-to-severe low back pain (Quebec Task Force Class 1 to 3) for ≥6 months.
  • Is opioid naïve (ie, taking <20 mg oxycodone/day or opioid equivalent) or is opioid experienced (ie, taking a dose between 20 and 240 mg [inclusive] oxycodone/day or opioid equivalent) for management of moderate-to-severe CLBP at least 14 days prior to screening and will, in the opinion of the investigator, continue to require opioid therapy (between 20 and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe CLBP for the duration of the study.
  • 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 and throughout the duration of the study), or is of non-childbearing potential

Exclusion Criteria:

  • Has cancer-related pain.
  • Has a history of receiving >240 mg oxycodone (or equivalent) daily within 30 days before screening.
  • Has a lumbar spinal infusion pump in use or used within 6 months before screening.
  • Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia)
  • Has positive urine drug toxicity screen for illegal or non-prescribed drugs
  • Has current (or history of within the last 5 years prior to screening) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine).
  • Has positive result for cannabinoids (even if legally prescribed).
  • Has a history of attempted suicide.

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): NCT02716857


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Sponsors and Collaborators
Egalet Ltd

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Responsible Party: Egalet Ltd
ClinicalTrials.gov Identifier: NCT02716857     History of Changes
Other Study ID Numbers: OC-EG-302
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Oxycodone
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents