Safety and Tolerability of Buprenorphine/Naloxone Film Strips - Tabular View

Tracking Information

First Received Date ^ICMJE

March 14, 2008

Last Updated Date

October 20, 2008

Start Date ^ICMJE

March 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00640835 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Tolerability of Buprenorphine/Naloxone Film Strips

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety Study

Condition ^ICMJE

Opioid-Related Disorders

Intervention ^ICMJE

Drug: Buprenorphine/naloxone Film Strip

Study Arms / Comparison Groups

Experimental: Buprenorphine/naloxone film strip administered sublingually
Experimental: Buprenorphine/naloxone film strip administered buccally

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

300

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00640835

Responsible Party

Rolley E. Johnson, Pharm.D./Vice-President, Clinical, Scientific & Regulatory Affairs, Reckitt Benckiser Pharmaceuticals Inc

Study ID Numbers ^ICMJE

RB-US-07-0001

Study Sponsor ^ICMJE

Reckitt Benckiser Pharmaceuticals, Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Donald R. Jasinski, MD

Johns Hopkins University

Information Provided By

Reckitt Benckiser Pharmaceuticals, Inc

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP