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Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence

This study has been completed.
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Orexo AB
ClinicalTrials.gov Identifier:
NCT01903005
First received: July 9, 2013
Last updated: September 28, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Opioid Dependence, on Agonist Therapy
Drug: Higher bioavailability BNX sublingual tablets
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Orexo AB:

Primary Outcome Measures:
  • Number of Patients Reporting Treatment-Emergent Adverse Events [ Time Frame: Day 1 through week 24 ] [ Designated as safety issue: Yes ]
    Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets

  • Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events [ Time Frame: Day 1 through week 24 ] [ Designated as safety issue: Yes ]
    Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets

  • Number of Patients Reporting Treatment-Emergent Serious Adverse Events [ Time Frame: Day 1 throught week 24 ] [ Designated as safety issue: Yes ]
    Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets

  • Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events [ Time Frame: Day 1 through week 24 ] [ Designated as safety issue: Yes ]
    Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets


Secondary Outcome Measures:
  • Retention in Treatment in the Safety Population [ Time Frame: Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit)

  • Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score [ Time Frame: Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint ] [ Designated as safety issue: No ]
    Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS

  • Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score [ Time Frame: Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint ] [ Designated as safety issue: No ]
    Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS

  • Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores [ Time Frame: Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint ] [ Designated as safety issue: No ]
    Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 ("no cravings") to 100 mm ("most intense craving I have ever had"); study endpoint was defined as the last post-baseline value recorded for VAS craving

  • 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) [ Time Frame: Study Endpoint ] [ Designated as safety issue: No ]
    Question 1 of the WPAI:SHP asks patients to provide a "yes" or "no" response to the question "Are you employed?"; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end

  • Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work?

  • Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities)


Enrollment: 668
Study Start Date: July 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label BNX sublingual tablets
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.
Drug: Higher bioavailability BNX sublingual tablets
Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks
Other Names:
  • OX219
  • Zubsolv
  • Buprenorphine/naloxone sublingual tablets

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903005

  Show 28 Study Locations
Sponsors and Collaborators
Orexo AB
Worldwide Clinical Trials
Investigators
Principal Investigator: Kent Hoffman TRY Research, 406 Lake Howell Road, Maitland, Florida 32751
  More Information

Responsible Party: Orexo AB
ClinicalTrials.gov Identifier: NCT01903005     History of Changes
Other Study ID Numbers: OX219-008 
Study First Received: July 9, 2013
Results First Received: August 17, 2015
Last Updated: September 28, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexo AB:
Opioid, Dependence, agonist, Buprenorphine, Naloxone

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Buprenorphine, Naloxone Drug Combination
Naloxone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists

ClinicalTrials.gov processed this record on December 09, 2016