Clinical Trials Register

Summary
EudraCT Number:	2012-001924-37
Sponsor's Protocol Code Number:	HJU1
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-11-05
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

2012-001924-37

A.3

Full title of the trial

Relaxation of the ureter during ureterorenoscopy

Relaksation af ureter under ureterorenoskopi

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Relaxation of the ureter during examination of the upper urinary tract

Afslapning af urinlederen under kikkertundersøgelse af øvre urinveje

A.4.1

Sponsor's protocol code number

HJU1

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	Fredericia Hospital
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	Fredericia Hospital
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	Fredericia Hospital
B.5.2	Functional name of contact point	Urological Research Center
B.5.3	Address:
B.5.3.1	Street Address	Dronningensgade 97
B.5.3.2	Town/ city	Fredericia
B.5.3.3	Post code	7000
B.5.3.4	Country	Denmark
B.5.4	Telephone number	4528599120
B.5.5	Fax number	4576237381
B.5.6	E-mail	helenejung@hotmail.com

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	No
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.3.1	Product name	isoprenalin
D.3.4	Pharmaceutical form	Concentrate and solvent for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Local use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ISOPRENALINE
D.3.9.1	CAS number	7683-59-2
D.3.9.2	Current sponsor code	Sponsor code not known
D.3.9.3	Other descriptive name	Isoproterenol
D.3.9.4	EV Substance Code	SUB08330MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.1
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Elevated pressure in the upper urinary tract during ureterorenoscopy

Forhøjet tryk i øvre urinveje under ureterorenoskopi

E.1.1.1

Medical condition in easily understood language

Elevated pressure in the kidney during endoscopic examination of the kidney and ureter

Forhøjet tryk i nyren under kikkertoperationer i nyre og urinleder

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10023436
E.1.2	Term	Kidney stone
E.1.2	System Organ Class	100000004857

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 if addition of isoprenalin in the irrigation fluid makes access to the upper urinary tract easier during ureterorenoscopy in case of a narrow ureter

At undersøge om tilsætning af isoprenalin i skyllevæsken under ureterorenoskopi gør adgangen til øvre urinveje lettere i tilfælde af en snæver/ svært passabel ureter

E.2.2

Secondary objectives of the trial

Per- and post-operative complications

Per- og postoperative komplikationer

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Indication for therapeutic semirigid ureterorenoscopy due to kidney stone.
Age > 18 years

Indikation for terapeutisk semirigid ureteroskopi på baggrund af nyresten
Alder > 18 år

E.4

Principal exclusion criteria

Allergy to isoprenalin
JJ-catheter in situ
Nephrostomy in situ
Known malignancies in baldder, kidney or ureter
Pregnancy
Lactation
Disempowered
In custody

Allergi overfor isoprenalin
JJ eller nefrostomi in situ
kendt malign sygdom i blære, urinleder eller nyre
graviditet
amning
umyndiggjort
frihedsberøvet

E.5 End points

E.5.1

Primary end point(s)

If addition of isoprenalin in the irrigation fluid makes it possible to pass ureter with the ureteroscope

Om tilsætning af isoprenalin til skyllevæsken gør det muligt at passere ureter med ureteroskop

E.5.1.1

Timepoint(s) of evaluation of this end point

during operation for kidney stone

under operation for nyresten

E.5.2

Secondary end point(s)

Per-and post-operative complications: infection and bleeding

per-og postoperative komplikationer: infektion og blødning

E.5.2.1

Timepoint(s) of evaluation of this end point

During the operation and until patient is discharged from hospital

under operationen og indtil udskrivelse ( 1-2 dage)

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

saltvand

saline

E.8.2.4

Number of treatment arms in the trial

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

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

last visit of the last subject undergoing the trial

når sidste patient er opereret og udskrevet

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

F.3.3.1

Women of childbearing potential not using contraception