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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

Tracking Information
First Submitted Date  ICMJE November 10, 2015
First Posted Date  ICMJE November 13, 2015
Last Update Posted Date March 5, 2018
Actual Study Start Date  ICMJE March 7, 2016
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02603705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Moderate-to-severe Chronic Noncancer Pain
Intervention  ICMJE Drug: Oxycodone extended-release
Study Arms  ICMJE Experimental: Oxycodone extended-release
Egalet abuse-deterrent, extended-release oxycodone tablet
Intervention: Drug: Oxycodone extended-release
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2016)
281
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2015)
250
Actual Study Completion Date  ICMJE June 15, 2017
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02603705
Other Study ID Numbers  ICMJE OC-EG-303
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Egalet Ltd
Study Sponsor  ICMJE Egalet Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Egalet Ltd
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP