Transfer of Subjects From Subutex/Suboxone to RBP-6300

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Reckitt Benckiser Pharmaceuticals Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01582347
First received: April 18, 2012
Last updated: June 5, 2013
Last verified: February 2012
  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:


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


Enrollment: 143
Study Start Date: March 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: July 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-IV-TEXT REVISION)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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
Prof. Dr. Fleischhacker
Austria, Austria, 6020
Dr. Lindenbauer
Linz, Austria, 4020
Prof. Dr. Wurst
Salzburg, Austria, 5020
Prof. Wolzt
Wien, Austria, 1090
Czech Republic
Dr. Vehak
Prague, Czech Republic, 1400
Dr. Stankova
Usti nad Labem, Czech Republic, 40113
Germany
Dr. Tietje
Bremen, Germany, 28719
Prof. Scherbaum
Essen, Germany, 45147
Dr. Weber
Kassel, Germany, 34117
PD. Dr. Pogarell
Munich, Germany, 80336
Dr. Rechenmacher
Oldenburg, Germany, 26121
Dr. Boniakowski
Regensburg, Germany, 93051
Dr. Issler
Stuttgart, Germany, 70197
Sweden
Dr. Kilaidakis
Orebro, Sweden, 70185
Dr. Georgieva
Stockholm, Sweden, 17176
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: 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
Principal Investigator: Claus Schubert, Dr Substitutionsambulanz Geinhausen
Principal Investigator: Chaim Jellinek a.i.d., Ambulanz fur integrierte Drogenhilfe
Principal Investigator: Karl Heinz Meller, Dr Praxis Dr. Meller
  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: June 5, 2013
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 July 22, 2014