Clinical trial NCT01903005: Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
Official title: A Multi-center, Open-Label, 24-Week, Follow-Up Study to Assess Safety, Efficacy, and Treatment Adherence For Maintenance Treatment of Opioid Dependence With OX219
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Dependence, on Agonist Therapy
Keywords: Opioid, Dependence, agonist, Buprenorphine, Naloxone
Lead sponsor: Orexo AB
Sponsor class: INDUSTRY
Collaborators: name: Worldwide Clinical Trials
First posted: 2013-07-19
Enrollment: 668
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This was a multicenter, open-label, uncontrolled, single-arm, 24-week, extension study to assess safety, efficacy, and treatment retention during maintenance treatment.

Eligible patients had completed 1 of 2 primary efficacy and safety studies of the higher-bioavailability BNX sublingual tablet formulation (primary study OX219-006 \[NCT01908842\] or OX219-007 \[NCT01848054\]). The total duration of study treatment was 24 weeks.

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).

Primary outcomes:
measure: Number of Patients Reporting Treatment-Emergent Adverse Events
timeFrame: Day 1 through week 24
measure: Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events
timeFrame: Day 1 through week 24
measure: Number of Patients Reporting Treatment-Emergent Serious Adverse Events
timeFrame: Day 1 throught week 24
measure: Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events
timeFrame: Day 1 through week 24
Secondary outcomes:
measure: Retention in Treatment in the Safety Population
timeFrame: Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24
measure: Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score
timeFrame: Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint
measure: Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score
timeFrame: Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint
measure: Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores
timeFrame: Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint
measure: 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)
timeFrame: Study Endpoint
measure: Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP
timeFrame: Week 24
measure: Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP
timeFrame: Week 24
Other outcomes:
Locations:
city: Jefferson County
country: United States
state: Alabama
city: Marion County
country: United States
state: Alabama
city: Winston County
country: United States
state: Alabama
city: Maricopa County
country: United States
state: Arizona
city: Los Angeles County
country: United States
state: California
city: San Diego County
country: United States
state: California
city: Broward County
country: United States
state: Florida
city: Columbia County
country: United States
state: Florida
city: Duval County
country: United States
state: Florida
city: Jacksonville metropolitan area
country: United States
state: Florida
city: Miami-Dade County
country: United States
state: Florida
city: Orlando metropolitan area
country: United States
state: Florida
city: Osceola County
country: United States
state: Florida
city: Palm Beach County
country: United States
state: Florida
city: DeKalb County
country: United States
state: Georgia
city: Chicago metropolitan area
country: United States
state: Illinois
city: Baltimore County
country: United States
state: Maryland
city: Bristol County
country: United States
state: Massachusetts
city: Rankin County
country: United States
state: Mississippi
city: St. Louis metropolitan area
country: United States
state: Missouri
city: Warren County
country: United States
state: New Jersey
city: Oklahoma County
country: United States
state: Oklahoma
city: Portland metropolitan area
country: United States
state: Oregon
city: Delaware County
country: United States
state: Pennsylvania
city: Philadelphia County
country: United States
state: Pennsylvania
city: Charleston County
country: United States
state: South Carolina
city: Salt Lake County
country: United States
state: Utah
city: Benton County
country: United States
state: Washington
Study officials:
affiliation: TRY Research, 406 Lake Howell Road, Maitland, Florida 32751
name: Kent Hoffman
role: PRINCIPAL_INVESTIGATOR
References: