Safety and Tolerability of Buprenorphine/Naloxone Film Strips - Full Text View

Purpose

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.

Condition	Intervention	Phase
Opioid-Related Disorders	Drug: Buprenorphine/naloxone Film Strip	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Reckitt Benckiser Pharmaceuticals Inc.:

Primary Outcome Measures:

Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows:

Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs
Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.

Enrollment:	382
Study Start Date:	February 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sublingual administration Buprenorphine/naloxone film strip administered sublingually	Drug: Buprenorphine/naloxone Film Strip Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route
Experimental: Buccal administration Buprenorphine/naloxone film strip administered buccally	Drug: Buprenorphine/naloxone Film Strip Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route

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

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640835

Locations

United States, Alabama
Parkway Medical Center
Birmingham, Alabama, United States, 35215
Winston Technology Research LLC
Haleyville, Alabama, United States, 35565
United States, Florida
Beeches Family Medicine
Jacksonville Beach, Florida, United States, 32250

Sponsors and Collaborators

Reckitt Benckiser Pharmaceuticals Inc.

Investigators

Principal Investigator:

Donald R. Jasinski, MD

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00640835 History of Changes
Other Study ID Numbers:	RB-US-07-0001
Study First Received:	March 14, 2008
Results First Received:	September 30, 2010
Last Updated:	November 6, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:

Opioid dependence

Additional relevant MeSH terms:

Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013