Transfer of Subjects From Subutex/Suboxone to RBP-6300 - Full Text View

Purpose

This study is designed to determine if opioid dependent subjects who are already receiving Subutex and/or Suboxone can transfer to RBP-6300. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex and/or Suboxone

Condition	Intervention	Phase
Opioid Related Disorder	Drug: RBP-6300 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Double-dummy, Active-drug-controlled, Parallel-group, Multicentre Acceptability and Safety Study of the Transfer From Subutex/Suboxone to RBP-6300 in Opioid-dependent Subjects

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Treatment [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
To demonstrate that RBP-6300 is not inferior to Subutex/Suboxone as assessed by the peak change from baseline in the pre-dose COWS score during the double-blind transfer phase

Secondary Outcome Measures:

Assess the overall clinical response to RBP-6300 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
One of the secondary objectives is to evaluate the safety and tolerability of RBP-6300 in terms of adverse events

Estimated Enrollment:	140
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: RBP-6300 Transfer and transition	Drug: RBP-6300 8, 16, 24mg daily, for 30 days
Placebo Comparator: Placebo 8mg to 24mg 3 day single blind transition phase placebo matching RBP-6300 and active Subutex/Suboxone	Drug: Placebo 8, 16, 24mg daily, 30 days

Eligibility

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

Criteria

Inclusion Criteria:

Be Male or non-pregnant, non-lactating females
Be at least 18 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders, DSM-IV-TR (Diagnostic and Statistical Manual)criteria for opioid dependence at screening
Be on stable dose of 8, 16, or 24mg/day for about 30 days prior to screening
Female subjects of childbearing potential must have a negative urine test prior to enrollment into the study

Exclusion Criteria:

Have participated in an experimental drug or device study within the last 60 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582347

Contacts

Contact: Christopher Morris, BSc, MSc

+44 1482 582675

Christopher.morris@rb.com

Locations

Austria
Prof. Dr. Fleischhacker	Recruiting
Austria, Austria, 6020
Contact: Wol;fgang Fleischhacker, Prof. Dr. +43 512 504 -0
Dr. Lindenbauer	Recruiting
Linz, Austria, 4020
Contact: Bernhard Lindenbauer, Dr. +43 5 055462-36565 michael.wolzt@meduniwien.ac.at
Prof. Dr. Wurst	Recruiting
Salzburg, Austria, 5020
Contact: Friedrick Wurst, Prof Dr. +43 662 4483-4601
Prof. Wolzt	Recruiting
Wien, Austria, 1090
Contact: Michael Wolzt, Prof. Dr. '0043-1-40400-2983 michael.wolzt@meduniwien.ac.at
Czech Republic
Dr. Vehak	Recruiting
Prague, Czech Republic, 1400
Contact: Vratislav Rehak, Dr. +420226216200 brzonova@remedis.cz
Dr. Stankova	Recruiting
Usti nad Labem, Czech Republic, 40113
Contact: Zdenka Stankova, Dr. 420602442767" zdenka.stankova@mnul.cz
Germany
Dr. Tietje	Recruiting
Bremen, Germany, 28719
Contact: Wieland Tietje, Dr. +49 421 163397-0 w.tietje@drs-tietje-heer.de
Prof. Scherbaum	Recruiting
Essen, Germany, 45147
Contact: Norbert Scherbaum, Prof. Dr. +49 201 7227 205 brzonova@remedis.cz
Dr. Weber	Recruiting
Kassel, Germany, 34117
Contact: Bernd Weber, Dr. +49 561 2079835 studien@praxisdrweber.de
PD. Dr. Pogarell	Recruiting
Munich, Germany, 80336
Contact: Oliver Pogarell, PD. Dr.
Dr. Rechenmacher	Recruiting
Oldenburg, Germany, 26121
Contact: Charlotte Rechenmacher, Dr. +49 171 1945 434 ch.rechenmacher@t-online.de
Dr. Boniakowski	Recruiting
Regensburg, Germany, 93051
Contact: Eduard Boniakowski, Dr. +49 941 69875911 psychosoziale.begleitung@t-online.de
Dr. Issler	Recruiting
Stuttgart, Germany, 70197
Contact: Edith Issler, Dr. +49 711 615532 288 lutze@schwabstrasse57.de
Sweden
Dr. Kilaidakis	Recruiting
Orebro, Sweden, 70185
Contact: Spyridon Kilaldakis, Dr. +46 196020526 lena.eriksson6@orebroll.se
Dr. Georgieva	Recruiting
Stockholm, Sweden, 17176
Contact: Georgieva, Dr. +46 8 51774656 camilla.lindblad@ki.se

Sponsors and Collaborators

Reckitt Benckiser Pharmaceuticals Inc.

Investigators

Principal Investigator:	Norbert Scherbaum, Prof. Dr.	Medical University, Duisburg-Essen, Germany
Principal Investigator:	Michael Wolzt, Prof. Dr.	Univ.-Klinik fur Klinische Pharmakologie, AKH Wien, Wien
Principal Investigator:	Bernhard Lindenbauer, Dr	Landesnervenklinik Wagner-Jauregg, Linz
Principal Investigator:	Friedrich Wurst, Prof. Dr.	Christian-Doppler-Klinik, Salzburg
Principal Investigator:	Wolfgang Fleischhacker, Prof. Dr.	Medical University Innsbruck
Principal Investigator:	Vratislav Rehak, Dr.	Remedis s.r.o., Prague
Principal Investigator:	Zdenka Stankova, Dr.	Masaryk Hospital, Usti nad Labem
Principal Investigator:	Oliver Pogarell, PD. Dr.	Medical University, Munich
Principal Investigator:	Bernd Weber, Dr.	Praxis Dr. Bernd Weber am Koenigsplatz Schwerpunkprax is fur Suchtmedizin, Kassel
Principal Investigator:	Edith Issler, Dr.	Infectomed GbR Zentrum fuer medizinische Studien, Stuttgart
Principal Investigator:	Wieland Tietje, Dr.	Drs. Tieje, Heer & Koc, Bremen
Principal Investigator:	Eduard Boniakowski, Dr.	Psychosoziale Begleitung - Praxis Boniakowski, Regensburg
Principal Investigator:	Charlotte Rechenmacher, Dr	Praxis Dr. Rechenmacher, Oldenburg
Principal Investigator:	Georgieva, Dr.	Karolinska Institute, Stockholm
Principal Investigator:	Spyridon Kilaidakis, Dr.	University Hospital Orebro

More Information

No publications provided

Responsible Party:	Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT01582347 History of Changes
Other Study ID Numbers:	RB-UK-11-0017
Study First Received:	April 18, 2012
Last Updated:	November 29, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Czech Republic: State Institute for Drug Control Austria: Federal Office for Safety in Health Care Sweden: Medical Products Agency

Keywords provided by Reckitt Benckiser Pharmaceuticals Inc.:

Opioid dependence

Additional relevant MeSH terms:

Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
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 19, 2013