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Open-label BNX sublingual tablets for Opioid Dependence
Phase 4
Waitlist Available
Led By Kent Hoffman
Research Sponsored by Orexo AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study endpoint
Awards & highlights
Summary
The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.
Eligible Conditions
- Opioid Dependence
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events
Number of Patients Reporting Treatment-Emergent Adverse Events
Number of Patients Reporting Treatment-Emergent Serious Adverse Events
+1 moreSecondary outcome measures
Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP
Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP
+4 moreSide effects data
From 2014 Phase 4 trial • 668 Patients • NCT019030053%
Constipation
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Population
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-label BNX sublingual tabletsExperimental Treatment1 Intervention
Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buprenorphine
FDA approved
Find a Location
Who is running the clinical trial?
Orexo ABLead Sponsor
6 Previous Clinical Trials
1,562 Total Patients Enrolled
1 Trials studying Opioid Dependence
9 Patients Enrolled for Opioid Dependence
Worldwide Clinical TrialsOTHER
62 Previous Clinical Trials
13,882 Total Patients Enrolled
Kent HoffmanPrincipal InvestigatorTRY Research, 406 Lake Howell Road, Maitland, Florida 32751
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