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    Summary
    EudraCT Number:2011-003047-22
    Sponsor's Protocol Code Number:RB-UK-11-0017
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2011-003047-22
    A.3Full title of the trial
    A Randomised, 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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    A.4.1Sponsor's protocol code numberRB-UK-11-0017
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorReckitt Benckiser Pharmaceuticals
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportReckitt Benckiser Pharmaceuticals Inc.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReckitt Benckiser Pharmaceuticals Inc.
    B.5.2Functional name of contact pointGlobal Clinical Development Manager
    B.5.3 Address:
    B.5.3.1Street AddressDansom Lane
    B.5.3.2Town/ cityHull
    B.5.3.3Post codeHU8 7DS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)1482 582675
    B.5.5Fax number+44(0) 1482 582603
    B.5.6E-mailchristopher.morris@rb.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name10 mg buprenorphine hemiadipate HCl and 10 mg naloxone HCl dihydrate
    D.3.2Product code RBP-6300
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRX778002A
    D.3.9.3Other descriptive nameBuprenorphine Hemiadipate Hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaloxone Hydrochloride Dihydrate
    D.3.9.1CAS number 51481-60-8
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB12168MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Suboxone 8 mg/2 mg Sublingual Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderRB Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSuboxone 8 mg/2 mg Sublingual Tablets
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBuprenorphine Hydrochloride
    D.3.9.1CAS number 53152-21-9
    D.3.9.3Other descriptive nameBUPRENORPHINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB13133MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaloxone Hydrochloride Dihydrate
    D.3.9.1CAS number 51481-60-8
    D.3.9.4EV Substance CodeSUB12168MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name SUBUTEX
    D.2.1.1.2Name of the Marketing Authorisation holderRB Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSubutex SL Tab 8mg
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBuprenorphine hydrochloride
    D.3.9.1CAS number 53152-21-9
    D.3.9.3Other descriptive nameBUPRENORPHINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB13133MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Suboxone 8 mg/2 mg Sublingual Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderRB Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSuboxone 8 mg/2 mg Sublingual Tablets
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBuprenorphine Hydrochloride
    D.3.9.1CAS number 53152-21-9
    D.3.9.3Other descriptive nameBUPRENORPHINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB13133MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaloxone Hydrochloride Dihydrate
    D.3.9.1CAS number 51481-60-8
    D.3.9.4EV Substance CodeSUB12168MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name SUBUTEX
    D.2.1.1.2Name of the Marketing Authorisation holderRB Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSubutex SL Tab 8mg
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBuprenorphine hydrochloride
    D.3.9.1CAS number 53152-21-9
    D.3.9.3Other descriptive nameBUPRENORPHINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB13133MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Maintenance/substitution agent for the treatment of opioid dependence
    E.1.1.1Medical condition in easily understood language
    Maintenance/substitution agent for the treatment of opioid dependence
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012346
    E.1.2Term Dependence on opiates
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate that RBP-6300 is not inferior to Subutex®/Suboxone® as assessed by the peak change from baseline in the pre-dose Clinical Opiate Withdrawal Scale (COWS) score during the Double-Blind Transfer Phase.
    E.2.2Secondary objectives of the trial
    Overall clinical response to RBP-6300 with respect to:
    • Mean change from baseline (D1) in pre-dose COWS score during Double-Blind Transfer Phase
    • Mean change from baseline (D1) in the COWS score during first 2h post-dosing on D1 of Double-Blind Transfer Phase
    • Mean change from baseline (D8) in pre-dose COWS score during Single-Blind Transition Phase
    • Mean change from baseline (D8) in COWS score during first 2h post-dosing on D8 (D1 of Single-Blind Transition Phase)
    • Peak and mean change from baseline in pre-dose SOWS
    • Illicit opioid and non-opioid drug use as measured by UDS
    • Drug craving as assessed using a 100 mm VAS
    • Illicit opioid and non-opioid drug use as measured by self-reporting on the SUI
    • Incidence of withdrawal due to clinically significant difficulties
    • Treatment compliance rate
    • Treatment retention rate
    For further secondary objectives please refer to protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be male or non-pregnant, non-lactating females.
    2. Subjects must be at least 18 years of age.
    3. Subjects must provide written informed consent and must be willing that their general practitioners be notified of their participation in the study.
    4. Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 3 months after the last dose of study drug. Women of childbearing potential are defined as all women who have not had a complete surgical hysterectomy or who cannot be documented as being at least 1 year postmenopausal. Medically acceptable forms of birth control include oral contraceptives, injectable or implantable methods, intrauterine devices, tubal ligation (if performed more than 1 year before screening), or double-barrier contraception. Use of two medically acceptable methods of birth control, one of which being a barrier method, may be needed according to local requirements or regulations (this will be reflected in the local informed consent form). Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug.
    5. Subjects must be able to communicate well with the investigator, understand and comply with the requirements of the study, and understand the written informed consent.
    6. Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) criteria for opioid dependence at screening.
    7. Subjects must have been receiving maintenance treatment with Suboxone®, Subutex® or generic Subutex ® at stable daily doses of 8, 16, or 24 mg/day for ≥30 days prior to screening and must be
    considered by the investigator to be suitable for continuing such treatment.
    8. Female subjects of childbearing potential must have a negative urine β-hCG or plasma (dependent on local regulations) test prior to enrolment into the study.
    E.4Principal exclusion criteria
    1. Subjects who are unwilling or unable to comply with the requirements of the protocol or who are in a situation or have a condition that, in the opinion of the investigator, may interfere with participation in the study.
    2. Subjects who, within 2 months prior to signing the informed consent document, participated in any other clinical study in which medications were delivered or who plan to participate in any other clinical study prior to the Follow-up Visit of the present trial.
    3. Subjects who are receiving treatment for opioid dependence by court order.
    4. Subjects with known allergy or sensitivity to buprenorphine or naloxone or to any of the excipients of Subutex®/Suboxone® or RBP6300.
    5. Subjects who are staff personnel or are affiliated with or a family member of staff personnel directly involved in the study.
    6. Subjects with serious untreated Axis I DSM-IV-TR psychiatric comorbidity (for example, those who are actively suicidal as per C-SSRS or have untreated schizophrenia).
    7. Subjects with significant benzodiazepine use requiring medical detoxification or alcohol dependence requiring medical detoxification. Current polysubstance abuse or dependence is not a reason for exclusion.
    8. Subjects with a current diagnosis of chronic pain requiring opioid treatment.
    9. Subjects with an ECG result that shows a repeated demonstration of a QTc interval >450ms or a history of risk factors of Torsades de Pointes (eg heart failure, hypokalemia,
    family history of Long QT Syndrome)
    10. Subjects with aspartate aminotransferase (AST) levels ≥3 × upper limit of normal (ULN), alanine aminotransferase (ALT) levels ≥3 × ULN, or total bilirubin levels ≥1.5 × ULN.
    11. Subjects with uncontrolled medical or psychiatric illness.
    12. Subjects currently using opioid treatment (except buprenorphine),
    other opioid derivatives (e.g., methadone and analgesics), clonidine and
    related substances and clinically relevant CYP3A4 inhibitors or inducers.
    13. Subjects with an opioid-positive (other than for buprenorphine) UDS result, a COWS score > 12, or a drug-craving VAS > 20 mm at screening or during the Open-Label Runin Phase.
    14. Subjects positive for human immunodeficiency virus (HIV), or showing evidence of acute hepatitis B or C infection—acute infection is defined as subjects positive for hepatitis B surface antigen (HBsAg) and immunoglobulin M antibodies to hepatitis B core antigen (anti-HBc IgM),
    and those with clinical evidence of either acute hepatitis B infection or hepatitis C infection. Subjects with chronic active hepatitis should also be excluded Subjects with asymptomatic hepatitis B or C infection and those asymptomatic currently being treated may be enrolled.
    15. Subjects for whom treatment with Subutex®/Suboxone® is a contraindication as per the Summary of Product Characteristics (SmPC), such as subjects with severe respiratory insufficiency or severe hepatic insufficiency.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the peak change from baseline in the pre-dose COWS score over the 7-day Double-Blind Transfer Phase (i.e., in the pre-dose COWS scores recorded on Days 2 to 8).
    E.5.1.1Timepoint(s) of evaluation of this end point
    COWS will be performed pre-dose and 1 and 2 hours (± 15 minutes) post-dose on Days 1 and 8 and pre-dose on all other days throughout the study (except for Visit 14, FU).
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    -mean change from baseline in COWS score during the Double-Blind Transfer Phase and the Single-Blind Transition Phase
    -The peak and mean change from baseline in SOWS score
    -number and percentage of subjects with a drug-free UDS
    - drug-craving VAS and SUI
    - incidence of withdrawal due to clinically significant difficulties
    - compliance rate
    - treatment retention rate

    Further secondary endpoints:
    - pharmacokinetics
    - safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    -COWS, SOWS and drug-craving VAS will be performed pre-dose and 1 and 2 hours (± 15 minutes) post-dose on Days 1 and 8 and pre-dose on all other days throughout the study (except for Visit 14, FU).
    - UDS and SUI will be performed at all visits (except for Visit 14, FU) throughout the study
    - compliance rate, treatment retention rate and safety will be assessed throughout the study
    - PK blood draws will be taken from Visit 3 to Visit 10
    - compliance rate, treatment retention rate and safety will be assessed throughout the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Non-inferiority trial
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double-dummy, open-label run-in, Double-blind Transfer Phase, Single-Blind Transition Phase
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the study, subjects will be remanded to further therapy under the care of their individual treating physicians
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-29
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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