Safety and Tolerability of Buprenorphine/Naloxone Film Strips
Information source: Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid-Related Disorders
Intervention: Buprenorphine/naloxone Film Strip (Drug); Buprenorphine/naloxone Film Strip (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Reckitt Benckiser Pharmaceuticals Inc. Official(s) and/or principal investigator(s): Donald R. Jasinski, MD, Principal Investigator, Affiliation: Johns Hopkins University
Summary
This study will evaluate the safety and tolerability on the oral mucosa of
buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12
weeks in opioid dependent individuals who are already on a stable regimen of
buprenorphine/naloxone.
Clinical Details
Official title: A Phase 2 Multi-Center Open-label Study to Assess the Safety and Tolerability of a Buprenorphine/Naloxone Film Strip Administered by the Sublingual and Buccal Routes
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity
Detailed description:
Buprenorphine and naloxone soluble film was developed as an alternative dosage form to
Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both
sublingual and buccal administration. The soluble film dosage is expected to provide the
following enhancements and potential advantages over the current Suboxone (buprenorphine and
naloxone) product:
- mitigation against unintentional pediatric exposure by providing child-resistant
packaging in unit dose format.
- improvement in subject convenience and compliance by ensuring rapid disintegration.
- protection against diversion by providing a dosage form that is very difficult for the
subject to remove from the sublingual or buccal mucosa after administration. This
provides assurance to the caregiver that the dose has actually been taken appropriately
in a supervised setting.
- provision of a unit dose product format for hospital and institutional use.
- decreased product damage during shipping as compared to Suboxone tablets.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Subjects must:
- Be 18-to-65 years of age, inclusive.
- Have a diagnosis of opioid dependence by medical history according to DSM-IV-TR
criteria.
- Be on stable dose of 4 to 32 mg (expressed as the buprenorphine component)daily of
Suboxone for at least 30 days.
- If female, have a negative pregnancy test during screening and agree to use an
acceptable method of birth control which may include:
Exclusion Criteria:
Subjects must not:
- Have participated in an experimental drug or device study within the last 30 days.
- If female, be breast feeding or lactating.
- Have any medical condition that in the opinion of the physician investigator would
preclude the subject from completing the study.
- Have a clinically significant abnormal finding (in the opinion of the Investigator)
on oral cavity exam (e. g., active mouth ulcers).
- Have any piercing of the tongue or mouth within 30 days prior to the first dose of
study medication.
Locations and Contacts
Parkway Medical Center, Birmingham, Alabama 35215, United States
Winston Technology Research LLC, Haleyville, Alabama 35565, United States
Beeches Family Medicine, Jacksonville Beach, Florida 32250, United States
Additional Information
Starting date: February 2008
Last updated: November 6, 2012
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