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

Sponsor:	Reckitt Benckiser Pharmaceuticals, Inc
Information provided by:	Reckitt Benckiser Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00640835

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
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: Buprenorphine Buprenorphine hydrochloride Naloxone hydrochloride Naloxone

U.S. FDA Resources

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

Primary Outcome Measures:

Severity and frequency of oral mucosal adverse events [ Time Frame: During active treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse events [ Time Frame: During active treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	March 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Experimental 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

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
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224

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 ( Rolley E. Johnson, Pharm.D./Vice-President, Clinical, Scientific & Regulatory Affairs )
Study ID Numbers:	RB-US-07-0001
Study First Received:	March 14, 2008
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00640835 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Reckitt Benckiser Pharmaceuticals, Inc:

Opioid dependence

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Naloxone
Buprenorphine

Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009