Phase 4
N=665
Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
Opioid Dependence, on Agonist Therapy
Bottom Line
View on ClinicalTrials.gov: NCT01903005 ↗Enrolled (actual)
665
Serious AEs
2.3%
Results posted
Oct 2015
Primary outcome: Primary: Number of Patients Reporting Treatment-Emergent Adverse Events — 20; 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Higher bioavailability BNX sublingual tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Orexo AB
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Reporting Treatment-Emergent Adverse Events |
20; 21 | — |
| PRIMARY Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events |
32; 19 | — |
| PRIMARY Number of Patients Reporting Treatment-Emergent Serious Adverse Events |
1; 8 | — |
| PRIMARY Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events |
14 | — |
| SECONDARY Retention in Treatment in the Safety Population |
563; 483; 425; 383; 333; 292 | — |
| SECONDARY Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score |
-12.0; -12.2; -12.7; -12.9; -13.1; -13.3 | — |
| SECONDARY Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score |
-26.8; -27.4; -28.0; -27.7; -28.7; -28.9 | — |
| SECONDARY Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores |
-52.8; -56.6; -59.4; -59.4; -61.5; -61.4 | — |
| SECONDARY Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP) |
21.3; 6.0; 15.3 | — |
| SECONDARY Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP |
-4.8; -0.2; 7.7 | — |
| SECONDARY Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP |
-3.9; -4.3 | — |
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.
Eligibility Criteria
Inclusion criteria
- Signed informed consent form.
- Completion of 1 of 2 primary efficacy safety studies of BNX sublingual tablets (OX219-006 or OX219-007).
- Female patients of child bearing potential who used a reliable method of contraception (hormonal, condom with spermicide, intrauterine device) during the previous OX219-006 or OX219-007 study and continue to use it for the OX219-008 study. Females who are not of child-bearing potential who are either surgically sterile (by hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation), or postmenopausal, as defined by being at least 50 years of age and having had an absence of menses for at least 2 years, were also eligible.
Exclusion criteria
- Females who are pregnant (positive pregnancy test result) or lactating, or planning to become pregnant during the study.
- Participants who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
- Participants who are participating in any other clinical study in which medication(s) are being delivered or who had used an investigational drug or device within the last 30 days.
- Participants with any known allergy or sensitivity or intolerance to buprenorphine, naloxone, or any related drug, or history of any drug hypersensitivity or intolerance that, in the opinion of the investigator, would compromise the safety of the subject or the study.
- Participant with a contra-indicated serious medical condition.
- Participants who are at suicidal risk as determined by any of the following: a history of suicidal ideation ≤ 3 months prior to baseline with a score of 4 (intent to act) or 5 (specified plan and intent) on the Columbia Suicide Severity Risk Scale (C-SSRS).
Data sourced from ClinicalTrials.gov (NCT01903005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.