Follow up Study to Assess Safety, Treatment Efficacy and Adherence of OX219 (Buprenorphine/Naloxone).

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Orexo AB
ClinicalTrials.gov Identifier:
NCT01903005
First received: July 9, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to assess treatment efficacy and adherence of OX219 (Buprenorphine/Naloxone).


Condition Intervention Phase
Opioid Dependence, on Agonist Therapy
Drug: buprenorphine/naloxone
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

Resource links provided by NLM:


Further study details as provided by Orexo AB:

Primary Outcome Measures:
  • To assess the safety and tolerability of OX219(AE) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: Yes ]
    Reported Adverse Events

  • To assess the safety and tolerability of OX219 (Vital Signs) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: Yes ]
    Blood pressure and pulse rate

  • To assess the safety and tolerability of OX219 (Safety laboratory tests) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: Yes ]
    Urine and blood samples (clinical chemistry and hematology)

  • To assess the safety and tolerability of OX219 (C-SSRS) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: Yes ]
    Assess suicidal ideation/behavior with Columbia Suicidal Severity Rating Scale (C-SSRS)

  • To assess the safety and tolerability of OX219 (Local tolerability assessments) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: Yes ]
    Visual examine of the mouth to check for any local irritation.


Secondary Outcome Measures:
  • Clinical Opiate Withdrawal Scale score (COWS) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Scale for assessment of opioid withdrawal symptoms by clinician

  • Subjective Opiate Withdrawal Scale score (SOWS) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Scale for assessment of opioid withdrawal symptoms by subject

  • Craving VAS [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Scale for assessment of treatment effects of opioid cravings

  • Urine drug screen (UDS) and/or urine dipstick [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Screen for illicit drugs/opioids/buprenorphine

  • Self report of substance use/opioid use [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Patient assessment of treatment effects on illicit drug use

  • Addiction Severity Index - Lite (ASI-Lite) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    To assess treatment effects on addiction severity.

  • Patient Global Impression of Improvement (PGI-I) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Patient assessment of improvement/deterioration of opioid dependence severity.

  • Clinical Global Impression of Severity (CGI-S) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Clinician assessment of opioid dependence severity.

  • Clinical Global Impression of Improvement (CGI-I) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Clinician assessment of improvement/deterioration of opioid dependence severity.

  • To evaluate retention in treatment during study period [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Recording of dose administrations

  • Pain Numerical rating scale (NRS) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: Yes ]
    Assessment of concomitant pain scale (numerical rating scale [NRS])

  • Patient Assessment of Constipation Symptoms (PAC-SYM) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: Yes ]
    To assess the patient perspective on constipation symptoms

  • SF-36 ratings [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Patient general quality of life questionnaire

  • Work productivity/activity impairment: Specific health problem questionnaire (WPAI:SHP) [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Patient questionnaire to evaluate the influence of opioid dependence on work capacity / other activities

  • To assess treatment compliance [ Time Frame: Participants will be followed for the duration of an expected average of 24 weeks ] [ Designated as safety issue: No ]
    Patient reported intake confirmed by drug accountability.


Estimated Enrollment: 700
Study Start Date: July 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
OX219
Week 1-24 OX219 buprenorphine/naloxone sublingual tablet (open-label)
Drug: buprenorphine/naloxone
OX219 buprenorphine/naloxone sublingual tablets

Detailed Description:

A multi-center-, open-label-, uncontrolled-, single armed-, 24-week, follow-up study to assess safety, efficacy and treatment adherence for maintenance treatment of opioid dependence with OX219.

Only patients from studies; OX219-006 or OX219-007 is permitted to participate

Total study treatment 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Signed informed consent form (ICF).
  2. Patient has completed the OX219-006 or the OX219-007 study.
  3. Female subjects of child bearing potential who use a reliable method of contraception (e.g. hormonal, condom with spermicide, IUD) during the previous OX219-006 or OX219-007 studies and during the duration of the OX219-008 study. Females of nonchild bearing potential who are either surgically sterile (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, tubal ligation), or post-menopausal as defined by being at least 50 years of age and having had an absence of menses for at least 2 years are also allowed.

Exclusion criteria

  1. Females who are pregnant (positive pregnancy test) or lactating, or planning to be pregnant during study.
  2. Participants who are unwilling or unable to comply with the requirements of the protocol (e.g., pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
  3. Participants who are participating in any other clinical study in which medication(s) are being delivered.
  4. Participants with any known allergy or sensitivity or intolerance to BUP, NAL or any related drug, or history of any drug hypersensitivity or intolerance which in the opinion of the investigator, would compromise the safety of the subject or the study.
  5. Participations with a contra-indicated serious medical condition.
  6. Participants who are at suicidal risk as determined by meeting any of the following: history of suicidal ideation ≤ 3 months prior to baseline with a score of 4 (intent to act) or 5 (specify plan and intent) on the C-SSRS; history of suicidal behavior (actual attempt, interrupted attempt, aborted attempt, and/or preparatory acts/behavior) on the 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 27 Study Locations
Sponsors and Collaborators
Orexo AB
Investigators
Principal Investigator: Kent Hoffman TRY Research, 406 Lake Howell Road, Maitland, Florida 32751
  More Information

No publications provided

Responsible Party: Orexo AB
ClinicalTrials.gov Identifier: NCT01903005     History of Changes
Other Study ID Numbers: OX219-008
Study First Received: July 9, 2013
Last Updated: May 6, 2014
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
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 14, 2014