Clinical Trials Register

Summary
EudraCT Number:	2011-000808-18
Sponsor's Protocol Code Number:	Concisus2012
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:	2012-01-12
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

2011-000808-18

A.3

Full title of the trial

Et randomiseret, dobbelt blindet, placebo kontrolleret, parallel gruppe klinisk studie af azithromycin hos patienter med Campylobacter concisus og diarré

A.3.1

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

Campylobacter concisus placebokontrolleret behandlingsstudie

A.3.2

Name or abbreviated title of the trial where available

Campylobacter concisus placebokontrolleret behandlingsstudie

A.4.1

Sponsor's protocol code number

Concisus2012

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	Aalborg Universitetshospital
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	Aalborg Sygehus
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	Infektionsmedicinsk Afd. Aalborg Sygehus
B.5.2	Functional name of contact point	Læge, Hans Linde Nielsen
B.5.3	Address:
B.5.3.1	Street Address	Hobrovej 18-22
B.5.3.2	Town/ city	Aalborg
B.5.3.3	Post code	9000
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+4599326532
B.5.5	Fax number	+4599326407
B.5.6	E-mail	halin@rn.dk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Azithromycin ”Ratiopharm”
D.2.1.1.2	Name of the Marketing Authorisation holder	Slotsmarken 12, st. tv. 2970 Hørsholm Denmark
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Azithromycin ”Ratiopharm”
D.3.2	Product code	22913
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	83905-01-5
D.3.9.3	Other descriptive name	AZITHROMYCIN
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	Yes
D.3.11.13.1	Other medicinal product type	Antibiotika tilhørende makrolid gruppen

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	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Et randomiseret, dobbelt blindet, placebo kontrolleret studie af azithromycin hos patienter med Campylobacter concisus og diarré.
Symptombilledet for den nyopdagede Campylobacter concisus er opkastning og diarré. Om patienterne kan have effekt af antibiotisk behandling er uafklaret. Formålet med undersøgelsen er derfor at undersøge om antibiotisk behandling af C. concisus diarré kan bedre diarré tilstanden og afkorte sygdomsvarigheden.

E.1.1.1

Medical condition in easily understood language

Formålet med undersøgelsen er at undersøge om antibiotisk behandling af diarré pga. C. concisus kan bedre diarré tilstanden og afkorte sygdomsvarigheden.

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

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	10007046
E.1.2	Term	Campylobacter diarrhoea
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Formålet med dette studie er, at undersøge effekten af den antibiotiske behandling med azithromycin hos patienter med diarré hvor Campylobacter concisus er isoleret fra patientens afføringsprøve som den eneste mikroorganisme. Der må således ikke være en anden kendt tarmpatogen mikroorganisme som konkurrende årsag til patientens symptomer. Effekten bestemmes ud fra spørgeskemaer, der belyser patientens almene helbredstilstand samt udvikling i diarré-sygdom.

E.2.2

Secondary objectives of the trial

Parallelt gennemføres et studie med dyrkning af C. concisus fra spyt og afføring, før og efter behandling, for at belyse om eradikation af C. concisus er mulig ved behandling med azithromycin.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inklusionkriterier
• Diarré patienter over 18 år med positiv dyrkning af Campylobacter concisus dyrkning i fæces.
• Fortsat diarré defineret som 3 eller flere vandtynde til grødede afføringer dagligt
eller
• 2 vandtynde til grødede afføringer, samt minimum et eller flere ledsagesymptomer, såsom mavesmerter, kvalme, opkastning eller feber.
• Symptomer igennem minimum 24 timer.
• Symptomdebut på maximalt 14 dage.
• Mundligt og skriftligt samtykke, med dokumentation for at alle relevante oplysninger om studiet er givet til patienten.
• Patienten skal være villig til og have mulighed for at møde til det planlagte besøg og overholde den planlagte studieplan.

E.4

Principal exclusion criteria

Eksklusionskriterier
• Allergi overfor azithromycin.
• Alder under 18.
• Graviditet eller amning.
• Positiv afføringsprøve for anden tarmpatogen mikroorganisme.
• Behandling med andet antibiotikum (på et hvilket som helst tidspunkt fra 14 dage før første afføringsprøve).
• Kronisk inflammatorisk tarmsygdom
• Kronisk diare af anden kendt årsag.
• Demens.
• Alvorlig sygdom mindre end 14 dage fra planlagt indgang i studiet.
• Patienten er i behandling med medicin, der har interaktion med azithromycin f.eks. ciclosporin eller amiodaron.
• Patienter involveret i planlægning eller udførelse af studiet.

E.5 End points

E.5.1

Primary end point(s)

Endepunkter
Endepunktet er ”ændring i daglige antal afføringer”, og sygdomsvarighed.
Effekten måles ved spørgeskemaer inklusiv ”diarré-dagbog”.

Det primære endepunkt:

• Antal dage til opnåelse af symptomfrihed = ”normal afføringsfrekvens”, tolket som < 3 afføringer/dag.

Sekundære endepunkter er:

• Antallet af daglige afføringer, indtil opnåelse af symptomfrihed.

• Forekomst af sekundære symptomer i form af mavesmerter, kvalme og opkastning

• Forekomst af bivirkninger sammenlignet med placebogruppen.

• Eradikation af C. concisus fra spyt og afføring.

E.5.1.1

Timepoint(s) of evaluation of this end point

Vil blive evalueret straks ved forsøget afslutning i Januar 2013.
Desuden vil Sponsorinvestigator naturligvis følge anbefalinger fra GCP-enheden.

E.5.2

Secondary end point(s)

Sekundære endepunkter er:

• Antallet af daglige afføringer, indtil opnåelse af symptomfrihed.

• Forekomst af sekundære symptomer i form af mavesmerter, kvalme og opkastning

• Forekomst af bivirkninger sammenlignet med placebogruppen.

• Eradikation af C. concisus fra spyt og afføring.

E.5.2.1

Timepoint(s) of evaluation of this end point

Vil blive evalueret straks ved forsøget afslutning i Januar 2013.
Desuden vil Sponsorinvestigator naturligvis følge anbefalinger fra GCP-enheden.

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)

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

Yes

E.8.1.6

Cross over

Yes

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

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

Projektet afsluttes når i alt 100 patienter er færdiginkluderet.
Projektet er tænkt at forløbe over et år i perioden 01022012 til 31012013

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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 2012-01-12.

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

Yes

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

100

F.4.2.2

In the whole clinical trial

100

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)

Sponsorinvestigator har telefonisk kontakt med patienten på 10.dagen efter studiestart. Ved fortsatte diarré-symptomer tilbydes ny klinisk kontrol ved Sponsorinvestigator og tilbud om "Cross-over" medicin, og der aftales ny kontakt 10 dage herefter. Ved fortsatte symptomer herudover, kan patienten evt blive henvist til udredning på Gastroenterologisk afd. hvis der skønnes behov herfor.

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

2012-01-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-12-31

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