Clinical Trials Register

Summary
EudraCT Number:	2017-004655-23
Sponsor's Protocol Code Number:	CR4056-2-03
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:	2020-11-05
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

2017-004655-23

A.3

Full title of the trial

A randomized, double-blind, active- and placebo-controlled, parallel
group, single dose, multicentre study to assess the analgesic effect of CR4056 in
postoperative dental pain

Studio randomizzato, in doppio cieco, controllato verso attivo e placebo, a gruppi paralleli, in dose singola, multicentrico per valutare l¿effetto analgesico di CR4056 nel dolore dentale postoperatorio

A.3.1

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

Randomized, double-blind study evaluating the effect of a single dose of CR4056 in postoperative dental pain compared with placebo or another active treatment

Studio randomizzato, in doppio cieco che valuta l¿effetto di una singola dose di CR4056 nel dolore dentale postoperatorio confrontato con un altro trattamento attivo o con placebo

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

CR4056-2-03

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	ROTTAPHARM BIOTECH S.R.L.
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	Rottapharm Biotech srl
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	Rottapharm Biotech srl
B.5.2	Functional name of contact point	Clinical Research, Senior Clinical
B.5.3	Address:
B.5.3.1	Street Address	via Valosa di Sopra, 9
B.5.3.2	Town/ city	Monza
B.5.3.3	Post code	20900
B.5.3.4	Country	Italy
B.5.4	Telephone number	00399066055
B.5.5	Fax number	00399066161
B.5.6	E-mail	nadia.brambilla@rottapharmbiotech.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	CR4056 150 mg
D.3.2	Product code	CR4056
D.3.4	Pharmaceutical form	Capsule, hard
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	1004997-71-0
D.3.9.2	Current sponsor code	CR4056
D.3.9.4	EV Substance Code	SUB168653
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	150
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	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	CR4056 100 mg
D.3.2	Product code	CR4056
D.3.4	Pharmaceutical form	Capsule, hard
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	1004997-71-0
D.3.9.2	Current sponsor code	CR4056
D.3.9.4	EV Substance Code	SUB168653
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	100
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	Celebrex 100 mg capsule rigide
D.2.1.1.2	Name of the Marketing Authorisation holder	Pharma PFE 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.3.1	Product name	CELEBREX
D.3.2	Product code	[N.A.]
D.3.4	Pharmaceutical form	Capsule, hard
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.3.8	INN - Proposed INN	CELECOXIB
D.3.9.1	CAS number	169590-42-5
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB01143MIG
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	100
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
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

Postoperative dental pain

Dolore dentale postoperatorio

E.1.1.1

Medical condition in easily understood language

Pain after extraction of a third molar

Dolore dopo estrazione del terzo molare

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10036276
E.1.2	Term	Postoperative analgesia
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 assess the analgesic efficacy of a single dose of CR4056 in patients with postoperative dental pain.

Valutare l'efficacia analgesica di una dose singola di CR4056 in pazienti con dolore dentale postoperatorio

E.2.2

Secondary objectives of the trial

To assess the safety and tolerability of a single dose of CR4056 in patients with postoperative dental pain

Valutare la sicurezza e la tollerabilit¿ di una dose singola di CR4056 in pazienti con dolore dentale postoperatorio

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed and dated informed consent obtained before undergoing any trial-specific
procedure.
2. Male or female aged =18 and =65 years, in good health as determined by past
medical history, physical examination, vital signs, ECG and laboratory tests.
3. Body Mass Index>18.5 and =35 kg/m2.
4. Planned elective dental surgical procedure consisting in the extraction of a
mandibular third molar with partial or complete bone impaction (with Class II or
III, position B or C using Pell and Gregor classification as confirmed by
presurgery x-ray available in the patient file as source data). Concomitant
extraction of the ipsilateral maxillary third molar is also accepted (while
concomitant extractions of any contralateral tooth or any other dental surgical
procedure is NOT accepted).
5. Willingness and capability to comply with the scheduled study visits, treatment
plan and study procedures (e.g. completion of the e-diary).

1. Consenso informato firmato e datato, ottenuto prima di cominciare qualsiasi procedura correlata allo studio.
2. Uomini o donne con età =18 e =65 anni, in buona salute come confermato da anamnesi, esame fisico, segni vitali, ECG e test di laboratorio.
3. Indice massa corporea >18.5 e =35 kg/m2.
4. Intervento chirurgico dentale pianificato per l’estrazione di un terzo molare mandibolare con inclusione ossea parziale o totale (Classe II o III, posizione B o C secondo la classificazione di Pell and Gregor, come confermato da una radiografia già eseguita e disponibile nella documentazione del paziente come dato sorgente). È accettata anche l’estrazione contemporanea del terzo molare mascellare ipsilaterale (mentre l’estrazione contemporanea di qualsiasi dente controlaterale o qualsiasi altro intervento di chirurgia dentale NON sono accettati).
5. Disponibilità e capacità di rispettare le visite dello studio programmate, il piano di trattamento e le procedure dello studio (per esempio, il completamento del diario elettronico).

E.4

Principal exclusion criteria

1. History of cardiovascular or cerebrovascular disease or presence of known significant risk factors for cardiovascular events.
2. History/known presence of coagulation or hematopoietic disease.
3. History/known presence of gastric/duodenal ulcers, gastrointestinal bleeding and inflammatory bowel diseases.
4. History/known presence or family history of malignant hyperthermia or anaesthesia-related events.
5. History of hypersensitivity to sulphonamides or other drugs.
6. Known allergy/hypersensitivity to the study drugs, or to any of their excipients.
7. History/known presence of hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (the study drugs contain lactose).
8. History of alcohol or drug (including analgesics) abuse =12 months before the screening visit.
9. Known surgical or medical condition of the GI, hepatic, or renal system that might significantly alter the absorption, distribution, or excretion of any drug
substance.
10. Any other known clinically relevant disease that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise
the patient’s safety during trial participation.
11. Serum alkaline-phosphatase, or gamma-glutamyl-transferase, or lipase greater
than 3-fold the upper limit of normal (ULN); alanine aminotransferase, or
aspartate aminotransferase, or total bilirubin greater than 2-fold ULN.
12. Creatinine clearance <30 ml/min.
13. Any other laboratory examination performed at screening with clinically relevant
findings, as judged by the Investigator.
14. 12-lead ECG with clinically relevant findings, as judged by the Investigator.
15. Contraindications for use of single dose celecoxib (see Celebrex® SmPC).
16. Contraindications for use of paracetamol (see Tachipirina® SmPC).
17. Use of drugs active on Central Nervous System (CNS) that cannot be withhold
at least 7 days before randomization and until 24 h after the administration of the
study drug.
18. Use of antithrombotic drugs, such as acetyl salicylic acid (oral doses
=325 mg/day) or of other antiplatelet/anticoagulant drugs (including warfarin,
heparin, rivaroxaban, and dabigatran) for the primary and secondary prevention
of cardiovascular events that cannot be withhold at least 7 days before
randomization and until 24 h after the administration of the study drug.
19. Use of drugs interacting with CYP450 enzymes that cannot be withhold at least
7 days before randomization and until 24 h after the administration of the study
drug.
20. Use of other investigational drugs within 30 days or 5 half-lives, whichever is
longer, before screening.
21. Difficulty in swallowing capsules/tablets.
22. Pregnant or lactating women.
23. Women of childbearing potential who do not agree to practice an effective
method of contraception from the enrolment up to 30 days after Investigational
Medicinal Product (IMP) intake.
24. Fertile men with a female partner of childbearing potential who do not agree to
use a condom from the enrolment up to 7 days after the IMP intake.
25. Any other condition that, in the opinion of the Investigator, may jeopardize the study conduct according to the protocol.

1. Storia di malattie cardiovascolari o cerebrovascolari o presenza di noti fattori significativi di rischio per eventi cardiovascolari.
2. Storia/presenza accertata di malattie emopoietiche o disturbi della coagulazione.
3. Storia/presenza accertata di ulcere gastriche/duodenali, sanguinamenti gastrointestinali e malattie infiammatorie intestinali.
4. Storia/presenza accertata o storia familiare di ipertermia maligna o eventi correlati all’anestesia.
5. Storia di ipersensibilità a solfonammidi o altri farmaci
6. Nota allergia/ipersensibilità ad altri farmaci in studio, o a qualsiasi loro eccipiente.
7. Storia/presenza accertata di problemi ereditari di intolleranza al galattosio, carenza di Lapp lattasi o malassorbimento di glucosio-galattosio (i farmaci in studio contengono lattosio).
8. Storia di abuso di alcol o farmaci (inclusi analgesici) =12 mesi prima della visita di screening.
9. Condizioni chirurgiche o mediche note del sistema GI, epatico o renale che potrebbero alterare in maniera significativa l’assorbimento, la distribuzione o l’escrezione dei farmaci.
10. Qualsiasi altra nota patologia clinicamente rilevante che, secondo lo Sperimentatore, potrebbe alterare le valutazioni di efficacia o di sicurezza o potrebbe compromettere la sicurezza del paziente durante la partecipazione allo studio clinico.
11. Fosfatasi alcalina o gamma glutamil transferasi o lipasi superiori a 3 volte il limite superiore di normalità (ULN); alanina aminotransferasi o aspartato aminotransferasi o bilirubina totale superiore a 2 volte ULN.
12. Clearance della creatinina <30 ml/min.
13. Qualsiasi altro esame di laboratorio eseguito allo screening con risultati anormali, giudicati clinicamente rilevanti dallo Sperimentatore.
14. ECG a 12 derivazioni con risultati anormali, giudicati clinicamente rilevanti dallo Sperimentatore.
15. Controindicazioni all’utilizzo di una dose singola di celecoxib (vedere il Riassunto delle Caratteristiche del Prodotto del Celebrex®).
16. Controindicazioni all’uso di paracetamolo (vedere il Riassunto delle Caratteristiche del Prodotto della Tachipirina®).
17. Uso di farmaci attivi sul sistema nervoso centrale (SNC) che non possono essere sospesi, almeno 7 giorni prima della randomizzazione e fino a 24 h dopo la somministrazione del farmaco in studio.
18. Uso di farmaci antitrombotici, come acido acetilsalicilico (dosi orali =325 mg/die) o altri farmaci antipiastrinici/anticoagulanti (inclusi warfarin, eparina, rivaroxaban e dabigatran) per la prevenzione primaria e secondaria di eventi cardiovascolari che non possono essere sospesi, almeno 7 giorni prima della randomizzazione e fino a 24 h dopo la somministrazione del farmaco in studio.
19. Uso di farmaci che interagiscono con gli enzimi del CYP450 che non possono essere sospesi, almeno 7 giorni prima della randomizzazione e fino a 24 h dopo la somministrazione del farmaco in studio.
20. Uso di altri farmaci sperimentali entro 30 giorni o 5 emivite, qualunque sia più lungo, prima dello screening.
21. Difficoltà nel deglutire capsule/compresse.
22. Donne in stato di gravidanza o in allattamento.
23. Donne in età fertile che non accettano di utilizzare un metodo contraccettivo efficace dall’arruolamento fino a 30 giorni dopo l’assunzione del farmaco sperimentale (IMP).
24. Uomini fertili con una partner femminile potenzialmente fertile che non accettano di utilizzare il preservativo dall’arruolamento fino a 7 giorni dopo l’ assunzione del farmaco sperimentale.
25. Qualsiasi altra condizione che, secondo l’opinione dello Sperimentatore, possa inficiare la conduzione dello studio secondo il protocollo.

E.5 End points

E.5.1

Primary end point(s)

Summed time-weighted Pain Intensity Difference (SPID8) using the 4-point categorical scale

Somma delle differenze di intensità del dolore pesate per il tempo (SPID8) utilizzando la scala categorica a 4 punti

E.5.1.1

Timepoint(s) of evaluation of this end point

Over 8 h after study drug administration

Nelle 8 ore dopo la somministrazione del farmaco in studio

E.5.2

Secondary end point(s)

Summed time-weighted Pain Intensity Difference (SPID) using the 4-point categorical scale; SPID using the 100 mm VAS; Pain Intensity Difference (PID) using both the 4-point categorical scale and the 100 mm VAS; Sollievo totale dal dolore (TOTPAR) ; Pain relief (PR) ; Summed, time-weighted PRID (sum of PID and PR scores) (SPRID) using the categorical scales; Patient¿s Global Evaluation of the study drug; Onset of analgesia as time to Perceptible PR and time to Meaningful PR; Maximum PID (peak-PID) using both the 4-point categorical scale and the 100 mm VAS; Maximum PR ; Percentage of patients taking rescue analgesic medication; Time-to-first rescue analgesic medication use; Safety

Somma delle differenze di intensit¿ del dolore pesate per il tempo (SPID) utilizzando la scala categorica a 4 punti; SPID usando la VAS 100 mm; Differenza dell¿intensit¿ del dolore (PID) usando sia la scala categorica a 4 punti che la VAS 100 mm; TOTal PAin Relief (TOTPAR); Sollievo dal dolore (PR); Somma di sollievo dal dolore e differenze dell¿intensit¿ del dolore pesati per il tempo (somma dei PID e PR) (SPRID) usando le scale categoriche; Valutazione Globale da parte del paziente del farmaco in studio; Inizio dell¿analgesia come tempo per sollievo dal dolore percettibile (PPR) e tempo per sollievo dal dolore significativo (MPR); Massimo del PID (picco-PID) usando sia la scala categorica a 4 punti che la VAS 100 mm; Massimo del PR; Percentuale dei pazienti che assumono il farmaco analgesico di salvataggio; Tempo al primo utilizzo del farmaco analgesico di salvataggio; Sicurezza

E.5.2.1

Timepoint(s) of evaluation of this end point

Over 4, 6, 12, 24 after study drug administration; Over 4, 6, 8, 12, 24 after study drug administration; at different time points up to 24 h post-dose; Over 4, 6, 8, 12, 24 after study drug administration; at the different time points up to 24 h post-dose; Over 4, 6, 8, 12, 24 h post-dose; 24 after study drug administration; Over 24 after study drug administration; during the first 8 h post-dose,; during the first 8 h post-dose; Over 24 after study drug administration; Over 24 after study drug administration; Over 24 after study drug administration

Nelle 4, 6, 12, 24 ore dopo la somministrazione del farmaco in studio; Nelle 4, 6, 8, 12, 24 ore dopo la somministrazione del farmaco in studio; a diversi punti temporali fino a 24 h dopo la somministrazione del farmaco; Nelle 4, 6, 8, 12, 24 ore dopo la somministrazione del farmaco in studio; a diversi punti temporali fino a 24 h dopo la somministrazione del farmaco; Nelle 4, 6, 8, 12, 24 dopo la somministrazione del farmaco; 24 ore dopo la somministrazione del farmaco in studio o ; Nelle 24 ore dopo la somministrazione del farmaco in studio; durante le prime 8 ore dopo la somministrazione del farmaco in studio; durante le prime 8 h dopo la somministrazione del farmaco in studio; Nelle 24 ore dopo la somministrazione del farmaco in studio; Nelle 24 ore dopo la somministrazione del farmaco

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)

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

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

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

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:

240

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

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

130

F.4.2

For a multinational trial

F.4.2.1

In the EEA

248

F.4.2.2

In the whole clinical trial

248

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)

Patient will be followed by dentist as clinical practice

I pazienti verranno seguiti dal dentista curante come da pratica clinica

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

2018-06-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-05-23

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

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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