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    Summary
    EudraCT Number:2011-005700-15
    Sponsor's Protocol Code Number:marha1983
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-28
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2011-005700-15
    A.3Full title of the trial
    Can 5-HT3 receptor antagonists be used to limit vomiting in rota- and norovirus infections?
    Kan 5-HT3 receptorantagonister användas för att begränsa kräkningar vid rota- och norovirusinfektion?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can 5-HT3 receptor antagonists be used to limit vomiting in rota- and norovirus infections?
    Kan 5-HT3 receptorantagonister användas för att begränsa kräkningar vid rota- och norovirusinfektion?
    A.3.2Name or abbreviated title of the trial where available
    Can 5-HT3 receptor antagonists be used to limit vomiting in rota- and norovirus infections?
    Kan 5-HT3 receptorantagonister användas för att begränsa kräkningar vid rota- och norovirusinfektion
    A.4.1Sponsor's protocol code numbermarha1983
    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 SponsorLennart Svensson Linköping University Medical Faculty
    B.1.3.4CountrySweden
    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 supportLennart Svensson
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLennart Svensson
    B.5.2Functional name of contact pointClinical trial Information
    B.5.3 Address:
    B.5.3.1Street AddressMolecular Virology, Lab 1 floor 13
    B.5.3.2Town/ cityLinköping
    B.5.3.3Post code581 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+46010103 88 03
    B.5.5Fax number+46010103 13 75
    B.5.6E-maillennart.t.svensson@liu.se
    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 Zofran (Ondansetron)
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKlein
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameZofran
    D.3.4Pharmaceutical form Oral solution
    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 INNONDANSETRON
    D.3.9.1CAS number 116002-70-1
    D.3.9.3Other descriptive nameZofran
    D.3.9.4EV Substance CodeSUB09445MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,8
    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 placeboOral suspension
    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
    Virus caused vomiting and effect of the antiemetic drug Ondansetron
    Virusorsakade kräkningar och effekten av antiemetiska läkemedlet Ondansetron
    E.1.1.1Medical condition in easily understood language
    Virus caused vomiting and effect of the antiemetic drug Ondansetron
    Virusorsakade kräkningar och effekten av antiemetiska läkemedlet Ondansetron
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    Investigate if Ondansetron can reduce vomiting in virus caused gastroenteritis.
    Undersöka om Ondansetron kan minska kräkningar vid virusorsakad gastroenterit.
    E.2.2Secondary objectives of the trial
    To favor treatment with oral rehydration therapy.
    Att underlätta behandling med oral vätskeersättning.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria are: Children who have vomited (not blood, not bile and not feaces) at least once during the last four hours and had at least one non-bloody diarrhea during the illness period, and most have a mild to moderate dehydration should be included in the study.
    Inklusionskriterier är: Barn som har kräkts (icke blod, icke galla och inte feaces) minst en gånger under de senaste 4 timmarna och haft minst en icke-blodig diarré under sjukdomsperioden, och som mest har en lätt till måttlig uttorkning skulle ingå i studien.
    E.4Principal exclusion criteria
    Exclusion criteria are: severe dehydration or other disease that may obscure the assessment of dehydreringsgraden (renal failure or hypoabluminemi), formerly Ondansetron allergy, previous abdominal surgery, fructose intolerance, use of antiemetics during the last 72 hours, and previous participation in the study. Other exclusion criteria are severe congenital heart defects, immune deficiency, malignancy, malnutrition, cystic fibrosis, sickle cell anemia, diabetes mellitus and features suggestive of a disease other than gastroenteritis on medical examination (such as focal neurological signs or signs of increased intracranial pressure, acute abdominal surgical condition and supraventricular tachycardia).
    Exklusionskriterier är: svår dehydrering eller annan sjukdom som kan maskera bedömningen av dehydreringsgraden (njursvikt eller hypoabluminemi), tidigare Ondansetronallergi, tidigare bukoperation, fruktosintollerans, användning av antiemetika under de senaste 72 timmarna, och tidigare deltagande i studien. Övriga exklusionskriterier är svåra medfödda hjärtfel, immunbrist, malignitet, malnutrition, cystisk fibros, sicklecellanemi, diabetes mellitus och fynd som tyder på en sjukdom annan än gastroenterit på läkarundersökning (såsom fokala neurologiska tecken eller tecken till förhöjt intrakraniellt tryck, akut buk med kirurgisk åkomma och supraventrikulär takykardi).
    E.5 End points
    E.5.1Primary end point(s)
    The patient is monitored for vomiting and diarrhea for 24 hours after treatment with ondansetron (1 dose). The the clinical trial for each patient is ended when a person from the study team has make an phone call for the 24-h follow-up. The phone call is between 24 to 72 hours after treatment.
    Patienten följs upp för kräkningar och diarre under 24 timmar efter behandling med Ondansetron (1 dos). För den enskilda patienten så avslutas det kliniska försöket efter att ett uppföljande samtal gjorts från en person i studieteamet. Telefonsamtalet görs mellan 24 till 72 timmar efter behandlingen av patienten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 24-72 hours after the Ondansetron/placebo dose, a person from the study team will give a phone call to obtain information about the patients condition, the numbers of vomiting, the number of diarrhea episodes and eventually side-effects. It is 24h follow-up after oral intake of ondansetron/placebo. After the phone call is finished the clinical trial is ended.
    Vid 24-72 timmar efter Ondansetron/placebo dos, kommer en person från forskningsteamet att ge ett telefonsamtal för att få information om hur patienten mår, antalet kräkningar, antal episoder av diarré och eventuella biverkningar. Det är 24-timmar uppföljning efter intag av ondansetron/placebo. Efter avslutat samtal så är den kliniska prövningen är avslutad.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    If rota- and norovirus induced vomiting can be reduced the treatment with ORT will be favored and the hospitalisation will be reduced. This will give a enourmous reduction in the economical issue of the disease and also save a lot of life in developing countries where the intra venous therapy is near impossible. Reduced vomitin will also limit the viral spread.
    Om man kan minska kräkningar vid rota- och norovirusinfektion så kommer ORT behandling att kunna underlättas och sjukhusvistelse kommer att minska. Detta ger en enorm minskning av den ekonomiska frågan om sjukdomen och det kommer även spara många barns liv, framförallt i utvecklingsländer där intra venös terapi är näst intill omöjligt. Minskade kräkningar innebär också minskad smittspridning.
    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
    The trial ends for the individual patient 24 hours after Ondamsetron/placebo -behandlingen, through a conversation in which a person from the study team calling home to the patient (24 to 72h after the oral dose of ondansetron/placebo) and obtain information about the the patiens wellness, number of vomiting, diarrhea episodes and eventually side-effects.The follow-up is only 24 h.
    Försöket avslutas för den enskilda patienten 24 timmar efter Ondamsetron/placebo -behandlingen, genom ett samtal där en person från studieteamet ringer hem till patienten (24 till 72h efter dosen av ondansetron/placebo) och får information om hur patienten mår, antal kräkningar, antal diarre episoder och eventuella biverkningar. Patienten följs upp i 24 timmar.
    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 months11
    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 Yes
    F.1.1Number of subjects for this age range: 215
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 80
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 120
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Parents will have to make decisions about participation in the study.
    Föräldrarna kommer att få ta beslut om deltagande i studien.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state215
    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
    Nej
    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 Decision2013-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-26
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