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    Summary
    EudraCT Number:2011-004294-87
    Sponsor's Protocol Code Number:1,2
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-25
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-004294-87
    A.3Full title of the trial
    Treatment of multi-organ bodily distress syndrome.
    A double-blinded placebo controlled trial of the effect of Imipramine (STreSS-3)
    Behandling af multi-organ bodily distress syndrome.
    Et dobbelt-blindet placebokontrolleret forsøg af effekten af Imipramin (STreSS-3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of patients with long-lasting health problems (chronic functional disorders) with Imipramine
    Behandling af patienter med langvarige helbredsproblemer (kroniske funktionelle lidelser) med Imipramin
    A.3.2Name or abbreviated title of the trial where available
    Stress-3
    Stress-3
    A.4.1Sponsor's protocol code number1,2
    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 SponsorPer Klausen Fink
    B.1.3.4CountryDenmark
    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 supportAarhus University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationResearch Clinic for Functional Disorders and Psychosomatics
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressBarthsgade 5,1
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4589494310
    B.5.5Fax number+4589494340
    B.5.6E-mailaarhus.ffl@rm.dk
    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 Imipramin "DAK" 25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNYCOMED Danmark A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical 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.3.8INN - Proposed INNIMIPRAMINE
    D.3.9.1CAS number 50-49-7
    D.3.9.4EV Substance CodeSUB08152MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 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 Imipramin "DAK" 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNYCOMED Danmark A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical 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.3.8INN - Proposed INNIMIPRAMINE
    D.3.9.1CAS number 50-49-7
    D.3.9.4EV Substance CodeSUB08152MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    F 45 Somatisation disorder and related disorders.
    Bodily distress syndrome is a new diagnosis that resembles F 45 Somatisation disorder, but with a more specific set of diagnostic criteria.
    F 45 Somatiseringstilstand og lignende tilstande.
    Bodily distress syndrome er en ny diagnose, der ligner F 45 Somatiseringstilstand, men dog med mere specifikke diagnostiske kriterier.
    E.1.1.1Medical condition in easily understood language
    Long-lasting health problems with no established medical origin, with moderate to servere impact on daily life.
    Langvarige helbredsproblemer uden kendt medicinsk forklaring med moderat til svær påvirkning på dagligdagsaktiviteter.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLT
    E.1.2Classification code 10041326
    E.1.2Term Somatoform disorders
    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 aim of this study is to test the effect of Imipramine in patients with multi-organ Bodily Distress Syndrome (BDS). BDS is a unifying diagnosis that encompasses a group of closely related conditions such as somatisation disorder, fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The project consists of a double-blinded placebo controlled trial of treatment with the tricyclic antidepressant Imipramine in dosages of 25-75 mg. Primary outcome is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I). Secondary outcome is functional level (physical, mental and social) measured by the SF-36.
    Formålet med dette studie er at undersøge behandlingseffekten af Imipramin på patienter med funktionel lidelse, defineret som multi-organ Bodily Distress Syndrome (BDS). BDS er en forenende diagnose, der indeholder en gruppe af tæt relaterede tilstande så som somatiseringstilstand, fibromyalgi, colon irritable og kronisk træthedssyndrom. Projektet består af et dobbelt-blindet placebokontrolleret forsøg af behandling med det tricykliske antidepressivum Imipramin i dosisområdet 25-75 mg. Primært effektmål er patientens selvvurderede symptombedring målt vha. Clinical Global Improvement Scale (CGI-I) og sekundært effektmål er funktionsniveau (fysisk, mentalt og socialt) målt vha. SF-36.
    E.2.2Secondary objectives of the trial
    Secondary aim is to show wheter Imipramine has effect both on painful symptoms and other symptoms of Bodily Distress Syndrome, measured by Visual Analogue Scale (VAS) and Functional Illness Checklist (Fic).
    Sekundært formål er vha. Visual Analogue Scale (VAS) og Funktionel Sygdomstjekliste, at vurdere Imipramins påvirkning af både smertefulde symptomer og andre symptomer ved Bodily Distress Syndrome.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Functional disorder defined as Bodily Distress Syndrome multi organ type with symptoms from at least three out of four symptom categories
    2. Moderate or severe impact on daily life
    3. Symptoms lasting for at least 2 years
    4. Age 20-50 years
    5. Born in Denmark or by Danish parents. The patients must understand, speak, write and read Danish.
    1. Funktionel lidelse defineret som Bodily Distress Syndrome multi organ type med symptomer fra minimum tre ud af fire symptomkategorier
    2. Moderat eller svær påvirkning af dagligdagsaktiviteter
    3. Tilstanden har stået på i min. 2 år
    4. Alder 20-50 år
    5. Født i Danmark eller af danske forældre. Patienten forstår, taler, læser og skriver dansk
    E.4Principal exclusion criteria
    Exclusion criteria
    1. Presence of other physical or mental illness if it is not possible to separate the symptoms of this illness from the symptoms of BDS
    2. Current major or moderate depressive disorder, continuous treatment because of this, other severe psychiatric disorder that demands treatment, or suicidal thoughts
    3. A lifetime diagnosis of psychosis, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
    4. Abuse of alcohol, narcotics, or drugs
    5. Pregnancy, breastfeeding or current pregnancy wish. Fertile women must use effective anticonception, (hormonal contraception, contraceptive injection, implant or patch, intrauterine system and device, vaginal ring).
    6. Treatment with all pain modulating drugs, e.g. all analgesics, antidepressants, antiepileptica and other types of medication with pain relieving properties must be discontinued at least two weeks before the treatment phase.
    7. Imipramine treatment in sufficient dosage within the last year, i.e. 25 mg daily continuously for at least 8 weeks.
    8. Allergy to study medication or excipients in study medication.
    9. Myocardial infarction, congestive heart failure, signs of conduction defects or abnormalities on ECG (first degree AV-block, bundle branch block or prolonged QT-interval), narrow-angle glaucoma, porphyria, inherited galactose intolerance, epilepsy, hepatic insufficiency, and severe renal impairment
    10. Simultaneous use of:
    - antipsychotics
    - oral anticoagulantia
    - diuretics
    - sympatomimetica and CNS-stimulating drugs (amphetamine-like drugs)
    - all serotonergic drugs, e.g. SSRI, SNRI and TCA, the dietary supplement pericum (hypericum perforatum), monoamine oxidase (MAO) inhibitors, triptans, tramadol, petidin and tryptofan
    - the drugs cimetidin (H2-antagonist), quinidin (antiarrythmica), cclonidin (antihypertensive), fluconazol (antimycotica), clindamycin, clarithromycin, erythromycin (antibiotic), droperidol (anaesthetic), levodopa (antiparkinson), mefloquin (antimalaria), phenytoin, barbiturates, carbamazepin (antiepilepitica), hydroxizin (antihistamine), buspiron (anxiolytica)
    - Bupropion (tobacco dependence), celecoxib (NSAID), cinacalcet (antiparatyroidea drug), duloxetine (SNRI), flufenazin (antipsychotic), fluoxetine (SSRI), gefitinib (antineoplastic), moclobemid (MAO), paroxetin, sertralin (SSRI), terbinafin (antimycotica), yohimbine (erectil dysfunction) and fluvoxamin (SSRI), ciprofloxacin and enoxacin (microbiotic), because plasma concentration of imipramine can increase with simultaneous use of these potent CYP2D6- and CYP1A2- inhibitors.
    Eksklusionskriterier
    1. Tilstedeværelse af anden fysisk eller psykisk lidelse, hvis symptomerne på denne lidelse ikke klart kan adskilles fra symptomer på BDS
    2. Patienter med aktuel moderat eller svær depression, patienter i vedligeholdelsesbehandling pga. moderat eller svær depression, og patienter med anden svær behandlingskrævende psykisk lidelse eller suicidalrisiko
    3. En lifetime-diagnose af psykose, mani eller depression med psykotiske symptomer (ICD-10: F20-29, F30-31, F32.3, F33.3)
    4. Misbrug af alkohol, euforiserende stoffer eller medicin
    5. Graviditet, amning og aktuelt graviditetsønske. Fertile kvinder skal anvende sikker antikonception, dvs. spiral eller hormonel antikonception (p-piller, implantat, transdermal depotplastre, vaginalring eller depotinjektion).
    6. Behandling med al smertemodulerende medicin, dvs. analgetica, antidepressiva, antiepileptika og anden type smertestillende medicin skal stoppes mindst 2 uger inden behandlingsstart.
    7. Behandling med Imipramin i sufficient dosis inden for det sidste år, dvs. 25 mg dagligt i mindst 8 uger.
    8. Allergi overfor Imipramin eller et eller flere af hjælpestofferne.
    9. Patienter med tidligere myokardie-infarkt, hjerteinsufficiens eller tegn på forringet overledning på ekg (førstegrads AV-blok, grenblok eller forlænget QT-interval), snævervinklet glaucom, porfyri, arvelig galactoseintolerans, epilepsi, leverinsufficiens og svær nyreinsufficiens,
    10. Samtidig brug af følgende præparater:
    - antipsykotika
    - orale antikoagulantia
    - diuretika
    - sympatomimetika og CNS-stimulerende midler (amfetamin-lignende stoffer)
    - alle serotonerge stoffter, fx SSRI, SNRI og TCA, kosttilskudet perikum (hypericum perforatum), monoamine oxidase (MAO) inhibitorer, triptaner, tramadol, petidin og tryptofan.
    - præparaterne cimetidin (en H2-antagonist), quinidin (et antiarytmika), clonidin (et antihypertensivum), fluconazol (antimykotika), clindamycin, clarithromycin, erythromycin (antibakterielle midler), droperidol (anæstetika), levodopa (antiparkinson middel), mefloquin (antimalariamiddel), phenytoin, barbiturater, carbamazepin (antiepilepitika), hydroxizin (antihistamin), buspiron (anxiolytika)
    - præparaterne Bupropion (tobaksafvænning), Celecoxib (NSAID), Cinacalcet (antiparatyroidt middel.), duloxetin (SNRI), flufenazin (antipsykotika), Fluoxetin (SSRI), Geftinib (antineoplastisk middel), moclobemid (MAO), Paroxetin, Sertralin (SSRI), Terbinafin (antimykotika), Yohimbin (erektil dysfunktion) samt fluvoxamin (SSRI), ciprofloxacin og enoxacin (mikrobielle midler), idet plasmakoncentrationen af Imipramin kan øges ved brug af disse potente CYP2D6- og CYP1A2- inhibitorer
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I).
    Primært effektmål er patientens selvvurderede symptombedring målt vha. Clinical Global Improvement Scale (CGI-I).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical Global Improvement Scale (CGI-I) is rated by the patient after 10 weeks of sufficient dosage study medication (minimum 25 mg).
    Clinical Global Improvement Scale (CGI-I) besvares af patienten efter 10 uger med sufficient dosis af studiemedicinen (min. 25 mg).
    E.5.2Secondary end point(s)
    Secondary end point is functional level (physical, mental and social) measured by the SF-36, and symptom characterization measured by Visual Analogue Scale (VAS) og Functional Illness Checklist (Fic).
    Sekundært effektmål er funktionsniveau (fysisk, mentalt og socialt) målt vha. SF-36 og symptomkarakterisation vha. Visual Analogue Scale (VAS) og Funktionel Sygdomstjekliste.
    E.5.2.1Timepoint(s) of evaluation of this end point
    SF-36 questionnaire is given to the patient before inclusion and after 10 weeks of sufficient dosage study medication (minimum 25 mg).
    Visual Analogue Scale (VAS) og Functional Illness Checklist (Fic) is filled out before inclusion, at treatment start and after 10 weeks of sufficient dosage study medication (minimum 25 mg).
    SF-36 spørgeskema besvares af patienten før inclusion og efter 10 uger med sufficient dosis af studiemedicinen (min. 25 mg).
    Visual Analogue Scale (VAS) og Funktionel Sygdomstjekliste udfyldes af patienten inden inclusion, ved behandlingsopstart samt efter 10 uger med sufficient dosis af studiemedicinen (min. 25 mg).
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 No
    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
    Inclusion of patients ends when 140 patients are included in the study. For most patients, total study duration is 19 weeks, and the last visit is 6 weeks before that. End of trial is thus 6 weeks after LVLS. We expect this to be in early 2014.
    Inklusion af patienter stopper når 140 patienter en inkluderet. For de fleste patienter er der en samlet studievarighed på 19 uger, og det sidste besøg finder sted 6 uger før dette. Studieafslutning er således 6 uger efter LVLS. Vi forventer dette sker i begyndelsen af 2014.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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) No
    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 state140
    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)
    Plans for treatment after the trial are not different from the expected normal treatment of this condition.
    Forsøgspersonernes behandling efter forsøget adskiller sig ikke fra behandlingen af andre patienter med samme tilstand.
    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 Decision2011-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-01
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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