Clinical Trials Register

Summary
EudraCT Number:	2015-005111-32
Sponsor's Protocol Code Number:	ABO-MELI-15
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-04-04
Trial results	View 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

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-005111-32

A.3

Full title of the trial

Multicenter, Prospective, Comparative, Randomized Controlled Clinical investigation on the performance of Promelaxin® micro-enemas versus oral administration of Macrogol 4000, in the treatment of chronic constipation in infants aged between 6 and 24 months.

Indagine Clinica Multicentrica, Prospettica, Comparativa, Randomizzata, Controllata sulla prestazione di Microclismi a Base di Promelaxin® versus Macrogol 4000 per Via Orale nel Trattamento della Stipsi Cronica Funzionale in Lattanti di Età Compresa tra i 6 e i 24 Mesi.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

Not available

Non Disponibile

A.4.1

Sponsor's protocol code number

ABO-MELI-15

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	ABOCA S.P.A. SOCIETà AGRICOLA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Azienda Farmaceutica: Aboca SpA Società Agricola
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Aboca SpA Società Agricola
B.5.2	Functional name of contact point	Servizio Segreteria Aboca
B.5.3	Address:
B.5.3.1	Street Address	Frazione Aboca, 20
B.5.3.2	Town/ city	Sansepolcro (AR)
B.5.3.3	Post code	52037
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 0575 7461
B.5.5	Fax number	+39 0575 749130
B.5.6	E-mail	AMaidecchi@aboca.it

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	PAXABEL - 20 BUSTINE DI POLVERE PER SOLUZIONE ORALE DA 4 G
D.2.1.1.2	Name of the Marketing Authorisation holder	BEAUFOUR S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Paxabel 4g
D.3.4	Pharmaceutical form	Powder for oral suspension
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MACROGOL 4000
D.3.9.1	CAS number	25322-68-3
D.3.9.2	Current sponsor code	MACROGOL 4000
D.3.9.3	Other descriptive name	MACROGOL 40000
D.3.9.4	EV Substance Code	SUB175081
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Functional Constipation

Stipsi Cronica Funzionale

E.1.1.1

Medical condition in easily understood language

Constipation

Stitichezza

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10067374
E.1.2	Term	Stypsis
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 evaluate the performance, in terms of frequency of evacuations per week and in stool consistency,of the administration of evacuation enemas with Promelaxin® compared to Macrogol 4000 in the treatment of chronic constipation in infants aged between 6 and 24 months.

Valutare la prestazione, in termini di frequenza di evacuazioni per settimana e consistenza delle feci, della somministrazione di clisteri evacuativi contenenti Promelaxin® rispetto all’assunzione orale di Macrogol 4000 nel trattamento della stipsi cronica funzionale in lattanti e bambini di età compresa tra i 6 e i 24 mesi.

E.2.2

Secondary objectives of the trial

1. To evaluate safety and tolerability of Promelaxin® administered by rectal route, in infants and children affected by chronic functional constipation.
2. To evaluate the effects of the use of Promelaxin® administered by rectal route versus Macrogol 4000 administered orally on the quality of life of parents of infants and children aged between 6 and 24 months, affected by chronic functional constipation.
3. To evaluate the changes of the intestinal microbiota induced by the use of Promelaxin® administered by rectal route versus Macrogol 4000 adminitered orally.

1. Valutare la sicurezza e la tollerabilità dell’uso di Promelaxin® per via rettale in lattanti e bambini con stipsi cronica funzionale.
2. Valutare gli effetti dell’uso di Promelaxin® per via rettale versus Macrogol 4000 per via orale sulla qualità di vita dei genitori di lattanti e bambini di età compresa tra i 6 e i 24 mesi con stipsi cronica funzionale.
3. Valutare le modifiche del microbiota intestinale indotte dall’uso di Promelaxin® per via rettale versus Macrogol 4000 per via orale. information in other language that is applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age between 6 and 24 months
2. Diagnosis of chronic functional constipation according to the Roma III criteria (Appendix 3)
3. No theraphy with fecal softener within 7 days before the start of the study.
4. Informed consent signed by both parents or legal representative, indicating awareness of the investigational nature and of the risks of the study
5. Parents willing and able to attend the scheduled study visits , to fill in the diary and to follow the instructions of the Investigator

1. Età 6-24 mesi
2. Diagnosi di stipsi cronica funzionale secondo i Criteri di Roma III
3. Nessuna terapia con rammollitori fecali effettuata nei 7 giorni precedenti l’inizio dello studio
4. Firma del consenso informato da parte di entrambi i genitori o del tutore legale, indicante la consapevolezza della natura investigazionale e dei rischi dello studio
5. Disponibilità e possibilità da parte dei genitori a presentarsi alle visite prestabilite, a compilare il diario e a seguire le indicazioni dello Sperimentatore

E.4

Principal exclusion criteria

1. Suspicious or diagnosed constipation of organic nature
2. Delayed emission of meconium in the term newborn
3. Presence of severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease), toxic megacolon
4. Presence of digestive perforation or risk of digestive perforation
5. Presence of Ileus or suspicion of intestinal obstruction
6. Presence of painful abdominal syndromes of indeterminate cause
7. Hypersensitivity to macrogol (polyethylene glycol)or to any of the excipients
8. Hereditary problems of fructose intolerance
9. Known hypersensitivity or allergy to any component of Promelaxin
10. Presence of any other medical condition that contraindicates the use of Promelaxin® or Macrogol 4000

1. Sospetto o diagnosi di stipsi di natura organica
2. Ritardata emissione di meconio nel neonato a termine
3. Presenza di gravi malattie infiammatorie organiche del colon (come rettocolite ulcerosa, malattia di Crohn), megacolon tossico
4. Presenza di perforazione gastrointestinale o rischio di perforazione gastrointestinale
5. Presenza di ileo o sospetto di ostruzione intestinale o stenosi sintomatica
6. Presenza di dolori addominali da cause non determinate
7. Ipersensibilità individuale accertata verso macrogol (polietilenglicol) o uno qualsiasi degli eccipienti del prodotto
8. Problemi ereditari di intolleranza al fruttosio
9. Nota ipersensibilità o allergia ai componenti di Promelaxin
10. Presenza di ogni altra significativa condizione medica che controindichi l’utilizzo di Promelaxin® o Macrogol 4000

E.5 End points

E.5.1

Primary end point(s)

Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation.

Miglioramento della stipsi valutato come riduzione dei sintomi tipici della stipsi cronica funzionale

E.5.1.1

Timepoint(s) of evaluation of this end point

Days: 14, 21 and 56

Giorni: 14, 21 e 56

E.5.2

Secondary end point(s)

1
Score of the quality of life of parents calculated on day 21 and 56
2
Score of the quality of life of children calculated on day 21 and 56
3
Gastrointestinal symptoms in intfants on day 14, 21 and 56
4
Changes in the intestinal microbioma on day 21 and 56
5
Evaluation of the normalization of the intestinal activity measured by recording the frequency of evacuations and and stool consistency on day 14, 21 and 56
6
Products safety in terms of adverse events reported by parents / legal representative of the subject.

1
Score della qualità di vita dei genitori calcolato al giorno 21 e 56.
2
Score della qualità di vita dei bambini calcolato al giorno 21 e 56.
3
Sintomi gastrointestinali nei bambini al giorno 14, 21 e 56.
4
Modifiche del microbioma intestinale al giorno 21 e 56.
5
Valutazione della normalizzazione dell'alvo misurato attraverso la registrazione della frequenza e della consistenza delle feci rispetto al ricorso all’impiego del prodotto in studio al giorno 14, 21 e 56.
6
Sicurezza dei prodotti in termini di eventi avversi riportati dai genitori/tutore legale del soggetto.

E.5.2.1

Timepoint(s) of evaluation of this end point

1
On day 21 and 56
2
On day 21 and 56
3
On day 14, 21 and 56
4
On day 21 and 56
5
On day 14, 21 and 56
6
On day 14, 21 and 56

1
Al giorno 21 e 56
2
Al giorno 21 e 56
3
Al giorno 14, 21 e 56
4
Al giorno 21 e 56
5
Al giorno 14, 21 e 56
6
Al giorno 14, 21 e 56

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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

Microclismi a base di Promelaxin® (Melilax Pediatric) per uso rettale. Dispositivo Medico di classe

Micro-enemas with Promelaxin® (Melilax Pediatric) for rectal use. Medical device class IIb

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

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

Yes

F.1.1

Number of subjects for this age range:

120

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

F.3.3.2

Women of child-bearing potential using contraception

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subjects under age

Minori

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

120

F.4.2.2

In the whole clinical trial

120

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

Nessuno

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

2016-02-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-02-24

P. End of Trial
P.	End of Trial Status	Completed

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