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    Summary
    EudraCT Number:2015-004463-37
    Sponsor's Protocol Code Number:140682
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-27
    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 ConcernedNorway - NOMA
    A.2EudraCT number2015-004463-37
    A.3Full title of the trial
    ACUTE AND LONG-TERM EFFECTS OF INTRANASAL OXYTOCIN IN ALCOHOL WITHDRAWAL AND DEPENDENCE: A PROSPECTIVE RANDOMIZED PARALLEL GROUP PLACEBO-CONTROLLED TRIAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ACUTE AND LONG-TERM EFFECTS OF OXYTOCIN NASAL SPRAY IN ALCOHOL WITHDRAWAL AND DEPENDENCE: COMPARING TWO GROUPS OF PATIENTS WHERE ONE GROUP RECEIVES PLACEBO SPRAY.
    A.4.1Sponsor's protocol code number140682
    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 SponsorSt. Olavs Hospital
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSt. Olavs Hospital
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLade Behandlingssenter
    B.5.2Functional name of contact pointPI's representative(Katrine Melby)
    B.5.3 Address:
    B.5.3.1Street AddressLade Allé 86
    B.5.3.2Town/ cityTrondheim
    B.5.3.3Post code7041
    B.5.3.4CountryNorway
    B.5.4Telephone number+4792886639
    B.5.6E-mailkatrine.melby@ladebs.no
    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 Yes
    D.2.1.1.1Trade name Syntocinon
    D.2.1.1.2Name of the Marketing Authorisation holderSigma-Tau
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameSyntocinon
    D.3.4Pharmaceutical form Nasal spray, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic oxytocin (posterior pituitary hormone)
    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 placeboNasal spray, suspension
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    alcohol withdrawal and craving.
    E.1.1.1Medical condition in easily understood language
    alcohol withdrawal and craving.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    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 aim of the study is to test whether daily intranasal administration of oxytocin is more effective than placebo in decreasing the oxazepam dosages required to control withdrawal symptoms during a 3-day inpatient program of medical detoxification.
    E.2.2Secondary objectives of the trial
    The secondary aims are: 1) test whether daily intranasal administration of oxytocin is more effective than placebo in decreasing CIWA-Ar scores during the detoxification period; 2) test the effects on therapist- and self-reported withdrawal symptoms, dysphoria and Actigraph-assessed akathisia and sleep during the detoxification period; and 3) test whether daily intranasal self-administration of oxytocin is more effective than placebo on alcohol use measures (time to ‘relapse’ and amount, cravings), quality of sleep and mood states during a subsequent 4 week out-patient follow-up period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) At least one prior episode 2 days or longer in duration during which the subject experienced withdrawal symptoms that caused significant incapacitation (e.g., inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms of sufficient magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption; 2) average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study; 3) age 18-65; 4) consenting to participate in the study; 5) have residency in Sør-Trøndelag County after discharge
    E.4Principal exclusion criteria
    1) chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics; 2) dependence on substances other than alcohol, nicotine or caffeine; 3) inadequately treated, unstable and/or compromising medical or psychiatric conditions; 4) low body weight (BMI < 17) or history of anorexia nervosa or bulimia in the past 2 years; 5) pregnancy; parturition or breast-feeding in the past 6 months; 6) inability to read well enough to complete study questionnaires determined by whether the prospective subject can read the consent form without help and correctly answer basic questions about information in the consent form.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: Phase 1: Milligrams of oxazepam used to complete 3 days of detoxification. Phase 2: Time to ‘relapse’ and amount during 4 weeks of subsequent outpatient treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1: at the end of the three-day in-patient stay.
    Phase 2: after 4 weeks of outpatient treatment.
    E.5.2Secondary end point(s)
    Phase 1: CIWA-Ar-score, effects on mood, craving, sleep
    Phase 2: Effects on therapist- and self-reported withdrawal symptoms, dysphoria and Actigraph-assessed akathisia and sleep.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 1: at the end of the three-day in-patient stay.
    Phase 2: after 4 weeks of outpatient treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-01-27. Yes
    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 state40
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-30
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