Clinical Trials Register

Summary
EudraCT Number:	2022-002436-31
Sponsor's Protocol Code Number:	ALGIPED
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Not Authorised
Date on which this record was first entered in the EudraCT database:	2022-11-07
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2022-002436-31

A.3

Full title of the trial

Randomized, controlled, transversal phase IV study on the efficacy and speed of action of lysin ibuprofen vs ibuprofen on the treatment of acute pain in children (ALGIPED).

Studio randomizzato, controllato, trasversale di fase IV sull'efficacia e la rapidità di azione di ibuprofene lisinato vs ibuprofene nel trattamento del dolore acuto in età pediatrica (ALGIPED).

A.3.1

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

Study to evaluate the efficacy and rapidity of action of a drug containing ibuprofen lysinate vs a drug containing ibuprofen in the treatment of acute pain in pediatric age.

Studio per valutare l'efficacia e la rapidità di azione di un farmaco contenente ibuprofene lisinato vs un farmaco contenente ibuprofene nel trattamento del dolore acuto in età pediatrica.

A.3.2

Name or abbreviated title of the trial where available

ALGIPED

A.4.1

Sponsor's protocol code number

ALGIPED

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	Dicofarm S.p.A.
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	Dicofarma spa
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	Link Neuroscience and Healthcare srl - L.n.Age srl
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Via Mario Savini, 15
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00136
B.5.3.4	Country	Italy
B.5.6	E-mail	patrizia.maccari@lnage.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	NUROFEN FEBBRE E DOLORE - BAMBINI 200 MG/5 ML SOSPENSIONE ORALE GUSTO ARANCIA SENZA ZUCCHERO 1 FLACONE DA 150 ML CON SIRINGA DOSATRICE
D.2.1.1.2	Name of the Marketing Authorisation holder	RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED
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.3.4	Pharmaceutical form	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.3.9.2	Current sponsor code	N/A
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	20
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 2
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	ALGIDRIN
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.3.4	Pharmaceutical form	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.3.9.2	Current sponsor code	N/A
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	20
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 3
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	MOMENTKID - BAMBINI 100 MG/5 ML SOSPENSIONE ORALE FLACONE 150 ML CON SIRINGA DOSATRICE
D.2.1.1.2	Name of the Marketing Authorisation holder	AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO ACRAF SPA
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.3.4	Pharmaceutical form	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.3.9.2	Current sponsor code	N/A
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	20
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Acute pain in pediatric age

Dolore acuto in età pediatrica

E.1.1.1

Medical condition in easily understood language

Pain in children

Dolore nei bambini

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	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10066714
E.1.2	Term	Acute pain
E.1.2	System Organ Class	100000004867

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluation of the speed of action of lysin ibuprofen versus ibuprofen on the treatment of acute pain in children.

Obiettivo Primario: Valutazione della rapidità di azione di ibuprofene lisinato versus ibuprofene nel trattamento del dolore acuto in età pediatrica.

E.2.2

Secondary objectives of the trial

1. Evaluation of the efficacy of lysin ibuprofen versus ibuprofen on the treatment of acute pain in children.
2. Evaluation of safety of lysin ibuprofen versus ibuprofen on the treatment of acute pain in children.
3. AEs/SAEs manifested.

1. Valutazione dell’efficacia di ibuprofene lisinato versus ibuprofene nel trattamento del dolore acuto in età pediatrica.
2. Valutazione della sicurezza di ibuprofene lisinato versus ibuprofene nel trattamento del dolore acuto in età pediatrica.
3. Valutazione della sicurezza attraverso la raccolta degli AE/SAE.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and female pediatric subjects from 4 up to 14 years old.
2. Subjects admitted to PER with acute pain as a primary symptom or an accompanying symptom (sore throat, headache, ear pain, toothache, post-traumatic musculoskeletal pain).
3. Pain intensity =4, assessed with validated age-related scale.
4. Written informed consent provided by parents/tutor, willing and able to understand the pu rpose of the study, including possible risks and side effects, and willing and able to comply, on their behalf and of the minor, with the study requirements.
5. Willing and able to give additional written informed consent by itself, in case of children and adolescents, in addition to parents/tutor.
6. Willing and able, in case of children and adolescents, to comply with the study requirements on th eir behalf.

1. Soggetti di età compresa tra i 4 e i 14 anni n.c..
2. Soggetti che giungono in PSP per dolore acuto come motivo principale dell’accesso o come sintomodi accompagnamento (faringodinia, otalgia, cefalea, odontalgia, dolore muscolo-scheletrico posttraumatico).
3. Intensità del dolore =4, valutata con scala per la misurazione del dolore apposita per età.
4. Consenso informato scritto fornito dai genitori/tutor, disponibili e in grado di comprendere lo scopo dello studio, inclusi eventuali rischi ed effetti collaterali, e disposti e in grado di ottemperare, perconto loro e del minore, ai requisiti dello studio.
5. Disponibilità e capacità a fornire, oltre ai genitori/tutori, il proprio consenso informato scrittoaggiuntivo, in caso di bambini e adolescenti.
6. Volontà e capacità, nel caso di bambini e adolescenti, di ottemperare ai requisiti di studio per loro conto.

E.4

Principal exclusion criteria

1. Subjects with hypersensitivity to ibuprofen or any other NSAID.
2. Chicken pox.
3. Dehydration.
4. Gastroenteritis.
5. Renal failure.
6. Thrombocytopenia, coagulopathies, and haemorrhagic diathesis.
7. Head and abdominal trauma.
8. The analgesic pain/ anti-inflammatory has already been administered at home (paracetamol in the previous 4 hours or ibuprofen in the previous 6 hours).
9. Subjects affected by delayed psychomotor development.
10. Vomiting after drug administration (drop out).
11. Participation in any other clinical study within the 3 months prior to the screening.

1. Soggetti con ipersensibilità all’ibuprofene o a qualsiasi altro FANS.
2. Varicella.
3. Disidratazione.
4. Gastroenterite.
5. Insufficienza renale.
6. Piastrinopenia, coagulopatie e diatesi emorragica.
7. Trauma cranico e addominale.
8. La somministrazione dell’analgesico è già avvenuta a domicilio (somministrazione di paracetamolo
nelle precedenti 4 ore oppure ibuprofene nelle precedenti 6 ore).
9. La valutazione del dolore risulti inficiata dalla condizione di base, come pazienti con ritardo dello
sviluppo psicomotorio.
10. Vomito dopo la somministrazione di farmaci (abbandono).
11. Partecipazione a qualsiasi altro studio clinico nei 3 mesi precedenti lo screening.

E.5 End points

E.5.1

Primary end point(s)

The assessment of the primary endpoint is the reduction of pain (PAR) of the values of th e m easu res of the pain intensity with validated age-related scale into the two groups after 5 minutes.

La riduzione del dolore (abbreviato PAR, da sollievo dal dolore) sarà valutata in momenti diversi sulldifferenza dei valori delle scale del dolore utilizzate. La valutazione principale è a cinque minuti.

E.5.1.1

Timepoint(s) of evaluation of this end point

5 minutes

5 minuti

E.5.2

Secondary end point(s)

1. Evaluation of reduction of pain (PAR) after 10 minutes, 20 minutes, 30 minutes (for all data available) and total (added the reduction in the three/four phase)
2. General evaluation of AEs/SAEs.

1. Valutazione del punteggio generale PAR dopo 10 e 20 minuti (30 minuti non obbligatorio).
2. Valutazione di AE/SAE.

E.5.2.1

Timepoint(s) of evaluation of this end point

10, 20, 30 minutes

10, 20, 30 minuti

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

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)

Yes

E.8.2.2

Placebo

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

Information not present in EudraCT

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.1.1.1

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

192

F.4.2

For a multinational trial

F.4.2.1

In the EEA

192

F.4.2.2

In the whole clinical trial

192

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)

At the PI's discretion

A discrezione dello sperimentatore principale

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

2023-03-08

Ethics Committee Opinion of the trial application

Not-Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-05-16

P. End of Trial
P.	End of Trial Status	Not Authorised

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