Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT02716857
Status:
COMPLETED
Last Update Posted:
2018-03-05
First Post:
2016-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
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'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime.', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Efficacy: daily (past 24 hours) worst pain intensity score (WPI)', 'timeFrame': '16 Weeks'}, {'measure': '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', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Moderate-to-severe Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is an English-speaking man or woman between 18 and 75 years of age who has given written informed consent.\n* Has a clinical diagnosis of moderate-to-severe low back pain (Quebec Task Force Class 1 to 3) for ≥6 months.\n* 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.\n* Has stable health, as determined by the investigator,\n* 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\n\nExclusion Criteria:\n\n* Has cancer-related pain.\n* Has a history of receiving \\>240 mg oxycodone (or equivalent) daily within 30 days before screening.\n* Has a lumbar spinal infusion pump in use or used within 6 months before screening.\n* Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia)\n* Has positive urine drug toxicity screen for illegal or non-prescribed drugs\n* 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).\n* Has positive result for cannabinoids (even if legally prescribed).\n* Has a history of attempted suicide.'}, 'identificationModule': {'nctId': 'NCT02716857', 'briefTitle': 'Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Egalet Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'OC-EG-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxycodone extended-release', 'description': 'Egalet ADER oxycodone tablet', 'interventionNames': ['Drug: Oxycodone extended-release']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of Oxycodone extended-release', 'description': 'Egalet ADER oxycodone placebo tablet', 'interventionNames': ['Drug: Placebo of oxycodone extended-release']}], 'interventions': [{'name': 'Oxycodone extended-release', 'type': 'DRUG', 'otherNames': ['Egalet-002, Egalet 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