Clinical Trials Register

Summary
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

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

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A. Protocol Information

A.1

Member State Concerned

Denmark - DHMA

A.2

EudraCT number

2019-004610-34

A.3

Full 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.3.1

Title 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.3.2

Name or abbreviated title of the trial where available

DexaCup

A.4.1

Sponsor's protocol code number

DexaCup

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Rigshospitalet
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Candys Foundation
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	The Capital Region of Denmark
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
B.5.2	Functional name of contact point	Mikkel Larsen
B.5.3	Address:
B.5.3.1	Street Address	Blegdamsvej 3
B.5.3.2	Town/ city	København
B.5.3.3	Post code	2100
B.5.3.4	Country	Denmark
B.5.4	Telephone number	4535452071
B.5.6	E-mail	mikkel.hjordt.holm.larsen@regionh.dk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Dexa-Ratiopharm
D.2.1.1.2	Name of the Marketing Authorisation holder	Ratiopharm Gmbh
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dexamethasone
D.3.9.1	CAS number	312-93-6
D.3.9.3	Other descriptive name	DEXAMETHASONE PHOSPHATE
D.3.9.4	EV Substance Code	SUB01612MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous bolus use (Noncurrent)
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Postoperative pain following transoral robotic surgery

Postoperativ smerte ved transoral robotkirurgi

E.1.1.1

Medical condition in easily understood language

squamous cell carcinoma of unknown primary

Karcinommetastase på halsen fra ukendt primær tumor

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10036236
E.1.2	Term	Postoperative pain relief
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary end point(s)

Self assessed Pain intensity on a visual analoge scale (VAS)

Selvvurderet smerteniveau på visuel smerteskale (VAS)

E.5.1.1

Timepoint(s) of evaluation of this end point

During hospitalization and until 14 days after the procedure

Under indlæggelse og indtil 14 dage postoperativt

E.5.2

Secondary 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)

Indlæggelsesvarighed
Brug af p.n smertestillende
Postoperativ blødning
Postoperativ infektion
Postoperativ hyperglykæni
Selvvurderet Postoperativ kvalme og opkast
Reoperation
Tracheostomi
Genindlæggelse
Tid til NG-sonde fjernelse
selvvurderet konsistens af fødeindtag
Vægtforskel mellem indlæggelsesvægt og vægt ved udskrivelsen

E.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women 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.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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

ingen

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-04-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-06-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-11-09

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