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    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-003707-18
    Sponsor's Protocol Code Number:Evelien05
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-12-18
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003707-18
    A.3Full title of the trial
    Absorption of sublingual delivered fentanyl (Abstral®) in head and neck cancer patients treated with curatively aimed chemo-radiotherapy
    Absorptie van sublinguaal fentanyl (abstral) bij pt met hoofdhalskanker die behandeld worden met chemoradiatie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Absorption of sublingual delivered fentanyl (Abstral®) in head and neck cancer patients treated with curatively aimed chemo-radiotherapy
    Absorptie van sublinguaal fentanyl (abstral) bij pt met hoofdhalskanker die behandeld worden met chemoradiatie
    A.3.2Name or abbreviated title of the trial where available
    Absorption of fentanyl
    De opname van fentanyl
    A.4.1Sponsor's protocol code numberEvelien05
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Abstral
    D.2.1.1.2Name of the Marketing Authorisation holderProstrakan
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameAbstral
    D.3.2Product code PL 16508/0031
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    head and neck cancer patients treated with chemo-radiotherapy
    hoofdhalskankerpatienten die behandeld worden met chemoradiatie
    E.1.1.1Medical condition in easily understood language
    head and neck cancer patients treated with a combination of chemotherapy and radiotherapy
    hoofdhalskankerpatienten die behandeld worden met chemoradiatie
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary endpoint
    - The influence of mucositis on the plasma pharmacokinetics (primary AUC) of sublingually delivered fentanyl (Abstral ®) in patients during periods with and without mucositis.



    bestuderen van:
    - de invloed van mucositis op de absorptie van sublingaal fentanyl, bij patienten met hoofdhalskanker, die behandeld worden met chemoradiatie
    E.2.2Secondary objectives of the trial
    Secondary endpoint
    - The influence of xerostomia on the pharmacokinetics of sublingually delivered fentanyl (Abstral ®) in patients during periods with and without xerostomia.
    - The relation between absorption of sublingually delivered fentanyl and the local radiation dose.
    - de invloed van xerostomie op de absorptie van sublinguaal fentanyl
    - de relatie tussen absorptie van sublinguaal fentanyl en de lokale radiotherapie dosis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patients with head and neck cancer and planned treatment with chemo-radiotherapy
    - written informed consent
    - age > or = 18
    - no serious psychiatric illness, confusion or intellectual disability
    - patienten met hoofdhalskanker waarvoor behandeling met chemoradiatie
    - informed consent
    - leeftijd ouder of gelijk aan 18
    - geen ernstige psychiatrische ziekte, verwardheid of mentale retardatie
    E.4Principal exclusion criteria
    - use of fentanyl medication within one week before inclusion in the study (other opioid and non-opioid analgesics are allowed)
    - opioid intolerance
    - former allergic reactions to opioids
    - the use of cytochrome P450 (CYP) inhibitors or inducers is not an exclusion criterion by itself. However, the patient should not change its use during the sampling periods, to exlude altered CYP function on the PK of Abstral
    - gebruik van fentanyl 1wk voor inclusie in the studie (andere opiaten mogen wel)
    - intolerantie voor opioiden
    - eerdere allergische reactie op opioiden
    - het gebruik van cytochrome P450 (CYP) inhibitors of inducers is op zich geen contra-indicatie. Maar de pt moet dit gebruik niet veranderen gedurende de sampling periode.
    E.5 End points
    E.5.1Primary end point(s)
    - Auc, clearance
    - Auc, klaring
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years
    3 jaar
    E.5.2Secondary end point(s)
    - pain scores
    - CTC toxicity scores
    - xerostomia scores
    - pijn scores
    - CTX tox scores
    - xerostomie scores
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years
    3 jaar
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    eigen controle
    own control
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 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
    13 patients will be included and analysis will be performed on 10
    patients.
    13 patienten zullen geincludeerd en geanalyseerd worden.
    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 months0
    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 months0
    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: 13
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 13
    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
    geen
    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 Decision2013-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-22
    P. End of Trial
    P.End of Trial StatusOngoing
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