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    EudraCT Number:2019-004610-34
    Sponsor's Protocol Code Number:DexaCup
    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:2020-03-11
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2019-004610-34
    A.3Full title of the trial
    An investigation of postoperative pain, why still in hospital and days alive and out of hospital following transoral robotic surgery for squamous cell carcinoma of unknown primary
    Optimering af smertebehandling og en undersøgelse af hospitalisering og ”dage i live og hjemme” efter transoral robotkirurgi (TORS) for ukendt primær tumor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigation of postoperative pain, why still in hospital and days alive and out of hospital following transoral robotic surgery for squamous cell carcinoma of unknown primary
    Optimering af smertebehandling og en undersøgelse af hospitalisering og ”dage i live og hjemme” efter transoral robotkirurgi (TORS) for ukendt primær tumor
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberDexaCup
    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 SponsorRigshospitalet
    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 supportCandys Foundation
    B.4.1Name of organisation providing supportThe Capital Region of Denmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
    B.5.2Functional name of contact pointMikkel Larsen
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 3
    B.5.3.2Town/ cityKøbenhavn
    B.5.3.3Post code2100
    B.5.4Telephone number4535452071
    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. name Dexa-Ratiopharm
    D. of the Marketing Authorisation holderRatiopharm Gmbh
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexamethasone
    D.3.9.1CAS number 312-93-6
    D.3.9.3Other descriptive nameDEXAMETHASONE PHOSPHATE
    D.3.9.4EV Substance CodeSUB01612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative pain following transoral robotic surgery
    Postoperativ smerte ved transoral robotkirurgi
    E.1.1.1Medical condition in easily understood language
    squamous cell carcinoma of unknown primary
    Karcinommetastase på halsen fra ukendt primær tumor
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of high dose steroids on the postoperative pain level measured by self-assessed VAS during rest and swallowing following transoral robotic surgery
    At undersøge højdosis steroids effekt på det postoperative smerteniveau efter transoral robotkirurgi
    E.2.2Secondary objectives of the trial
    Length of stay, surgical complications, use of PRN pain medications, postoperative nausea and vomitting, unplanned readmissions, food intake consistensy, weight difference between admission and discharge, HPV status, location of a found primary tumor
    Indlæggelsesvarighed, kirurgiske komplikationer, brug af p.n. smertestillende medicin, postoperativ kvalme og opkast, ikke-planlagte genindlæggelser, konsistens af føde, vægtforskel mellem indlæggelse og udskrivelse, HPV status. placering af ved fund af primær tumor
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 18 years or older
    • Ability to provide a written informed consent
    • ECOG/WHO performance status 0-2
    • Squamous cell carcinoma of unknown primary
    • Booked for TORS based on radiologic and clinical assessment by the surgeon
    • Negative Urine HCG pregnancy test for women in the fertile age.
    1. 18 år eller ældre 

    2. I stand til at afgive informeret samtykke 

    3. WHO/ECOG-performance status 0-2 

    4. Karcinommetastase på halsen fra ukendt primærtumor
    5. Booket til transoral robot kirurgi baseret på radiologiske og kliniske fund vurderet ved operatør
    6. Negativ urin-HCG for kvinder i den fertile alder

    E.4Principal exclusion criteria
    • Serious medical comorbidities (ECOG/WHO performance status >2). Other contraindications to surgery
    • Distant metastasis
    • Active Herpes zoster
    • Previous head and neck cancer
    • Significant trismus, maximum inter-incisal opening  35mm
    • Insulin dependent diabetes
    • Allergy to glucocorticoids
    • Preoperative use of systemic glucocorticoids <90 days before the surgery
    • Preoperative use of biological anti-inflammatory medication <90 days before the surgery
    • Suspected active gastric ulcer by in the opinion of the investigator
    • Pregnancy/Breastfeeding
    1. Alvorlig medicinske komorbiditet (WHO-performance status >2) eller andre kontraindikationer i forhold til kirurgi. 

    2. Fjernmetastaser. 

    3. Tidligere hoved-hals kræft. 

    4. Trismus (nedsat mundåbning ≤ 35mm). 

    5. Insulin afhængig diabetes
    6. Glukokortikoid allergi
    7. Brug af systemisk glukokortikoid <90 dage før operation
    8. Brug af biologisk anti-inflammatorisk medicin <90 dage før operation
    9. Mistænkt aktivt mavesår, vurderet af inkluderende læge.
    10. Aktiv herpes zoster
    11. Graviditet/amning
    E.5 End points
    E.5.1Primary end point(s)
    Self assessed Pain intensity on a visual analoge scale (VAS)
    Selvvurderet smerteniveau på visuel smerteskale (VAS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    During hospitalization and until 14 days after the procedure
    Under indlæggelse og indtil 14 dage postoperativt
    E.5.2Secondary end point(s)
    • Length of hospitalization
    • Use of PRN pain medication
    • Postoperative bleeding (Any postoperative bleeding during the primary hospitalization)
    • Postoperative infection (Any postoperative infection during the primary hospitalization - Pneumonia must be verified by radiological examination)
    • Hyperglycemia (A preoperatively blood sugar sample will be performed. Blood sugar measurements will be obtained again at day 2 and 4)
    • Postoperative nausea and vomiting (Self-assessed and noted in the patient’s pain dairy)
    • Number of reoperations
    • Number of tracheotomy procedures (Peroperatively and postoperative during the first 30 days)
    • Unplanned readmission (Unplanned readmission to an department of otorhinolaryngology during the first 30 postoperative days )
    • Time to feeding tube removal if placed (Measured in days from tube placement until removal stated by a medical doctor - Additional feeding tube placement during the first 30 days will be noted in the patient CRF and are collected from the electronic journal )
    • Self-assessed food intake consistency during the first 14 days
    • Weight difference (Between admission weight and discharge weight)
    Brug af p.n smertestillende
    Postoperativ blødning
    Postoperativ infektion
    Postoperativ hyperglykæni
    Selvvurderet Postoperativ kvalme og opkast
    Tid til NG-sonde fjernelse
    selvvurderet konsistens af fødeindtag
    Vægtforskel mellem indlæggelsesvægt og vægt ved udskrivelsen
    E.5.2.1Timepoint(s) of evaluation of this end point
    During hospitalization and until 14 days postoperatively
    Under indlæggelsen og indtil 14 dag postoperativt
    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 No
    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. 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 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 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 concerned3
    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
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 2020-03-11. 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 state34
    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)
    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 Decision2020-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-09
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