Clinical Trials Register

Summary
EudraCT Number:	2015-005325-39
Sponsor's Protocol Code Number:	ELX-NPP-2016-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-05-17
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2015-005325-39

A.3

Full title of the trial

A RANDOMIZED, CONTROLLED, CLINICAL TRIAL TO COMPARE PERIPHERAL PARENTERAL NUTRITION (PeriOlimel N4-E) VS CONVENTIONAL FLUID THERAPY IN ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOL IN COLORECTAL CANCER SURGERY.

ESTUDIO CLÍNICO RANDOMIZADO ENTRE NUTRICIÓN PARENTERAL PERIFÉRICA VERSUS FLUIDOTERAPIA CONVENCIONAL EN PACIENTES INTERVENIDOS DE CÁNCER DE COLON EN RÉGIMEN DE FAST TRACK7 REHABILITACIÓN MULTIMODAL.

A.3.1

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

A.4.1

Sponsor's protocol code number

ELX-NPP-2016-01

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	Dr. Antonio Arroyo Sebastián
B.1.3.4	Country	Spain
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	Dr. Antonio Arroyo Sebastián
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dr. Antonio Arroyo Sebastián
B.5.2	Functional name of contact point	Dr. Antonio Arroyo Sebastián
B.5.3	Address:
B.5.3.1	Street Address	Camino de La Almazara 11
B.5.3.2	Town/ city	Elche
B.5.3.3	Post code	03203
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034966616377
B.5.5	Fax number	0034966616108
B.5.6	E-mail	arroyocir@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	Yes
D.2.1.1.1	Trade name	PERIOLIMEL N4E, emulsion for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	PERIOLIMEL N4E
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	REFINED OLIVE OIL AND REFINED SOYA OIL
D.3.9.3	Other descriptive name	REFINED OLIVE OIL AND REFINED SOYA OIL
D.3.9.4	EV Substance Code	SUB32333
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	45.00
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ALANINE
D.3.9.1	CAS number	56-41-7
D.3.9.3	Other descriptive name	ALANINE
D.3.9.4	EV Substance Code	SUB05290MIG
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	5.50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ARGININE
D.3.9.3	Other descriptive name	ARGININE
D.3.9.4	EV Substance Code	SUB05560MIG
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	3.72
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ASPARTIC ACID
D.3.9.1	CAS number	56-84-8
D.3.9.3	Other descriptive name	ASPARTIC ACID
D.3.9.4	EV Substance Code	SUB11721MIG
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	1.10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GLUTAMIC ACID
D.3.9.1	CAS number	56-86-0
D.3.9.3	Other descriptive name	GLUTAMIC ACID
D.3.9.4	EV Substance Code	SUB11991MIG
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	1.90
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GLYCINE
D.3.9.3	Other descriptive name	GLYCINE
D.3.9.4	EV Substance Code	SUB12000MIG
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	2.63
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HISTIDINE
D.3.9.1	CAS number	71-00-1
D.3.9.3	Other descriptive name	HISTIDINE
D.3.9.4	EV Substance Code	SUB08045MIG
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	2.26
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ISOLEUCINE
D.3.9.1	CAS number	73-32-5
D.3.9.3	Other descriptive name	ISOLEUCINE
D.3.9.4	EV Substance Code	SUB08320MIG
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	1.90
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEUCINE
D.3.9.3	Other descriptive name	LEUCINE
D.3.9.4	EV Substance Code	SUB08446MIG
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	2.63
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LYSINE
D.3.9.3	Other descriptive name	LYSINE
D.3.9.4	EV Substance Code	SUB08629MIG
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	2.99
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	METHIONINE
D.3.9.3	Other descriptive name	METHIONINE
D.3.9.4	EV Substance Code	SUB08850MIG
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	1.90
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PHENYLALANINE
D.3.9.1	CAS number	63-91-2
D.3.9.3	Other descriptive name	PHENYLALANINE
D.3.9.4	EV Substance Code	SUB09786MIG
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	2.63
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PROLINE
D.3.9.1	CAS number	147-85-3
D.3.9.3	Other descriptive name	PROLINE
D.3.9.4	EV Substance Code	SUB10082MIG
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	2.26
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SERINE
D.3.9.1	CAS number	56-45-1
D.3.9.3	Other descriptive name	SERINE
D.3.9.4	EV Substance Code	SUB10494MIG
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	1.50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	THREONINE
D.3.9.1	CAS number	72-19-5
D.3.9.3	Other descriptive name	THREONINE
D.3.9.4	EV Substance Code	SUB10989MIG
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	1.90
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRYPTOPHAN
D.3.9.1	CAS number	73-22-3
D.3.9.3	Other descriptive name	TRYPTOPHAN
D.3.9.4	EV Substance Code	SUB12377MIG
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	0.64
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TYROSINE
D.3.9.1	CAS number	60-18-4
D.3.9.3	Other descriptive name	TYROSINE
D.3.9.4	EV Substance Code	SUB11371MIG
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	0.10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VALINE
D.3.9.1	CAS number	72-18-4
D.3.9.3	Other descriptive name	VALINE
D.3.9.4	EV Substance Code	SUB00008MIG
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	2.43
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM ACETATE TRIHYDRATE
D.3.9.3	Other descriptive name	SODIUM ACETATE TRIHYDRATE
D.3.9.4	EV Substance Code	SUB15266MIG
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	1.73
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POTASSIUM CHLORIDE
D.3.9.3	Other descriptive name	POTASSIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12559MIG
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	1.79
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MAGNESIUM CHLORIDE HEXAHYDRATE
D.3.9.3	Other descriptive name	MAGNESIUM CHLORIDE HEXAHYDRATE
D.3.9.4	EV Substance Code	SUB12526MIG
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	0.67
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CALCIUM CHLORIDE DIHYDRATE
D.3.9.3	Other descriptive name	CALCIUM CHLORIDE DIHYDRATE
D.3.9.4	EV Substance Code	SUB12664MIG
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	0.44
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM GLYCEROPHOSPHATE HYDRATE
D.3.9.1	CAS number	1334-74-3
D.3.9.3	Other descriptive name	SODIUM GLYCEROPHOSPHATE HYDRATE
D.3.9.4	EV Substance Code	SUB90005
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	2.87
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CALCIUM CHLORIDE DIHYDRATE
D.3.9.3	Other descriptive name	CALCIUM CHLORIDE DIHYDRATE
D.3.9.4	EV Substance Code	SUB12664MIG
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	0.44
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GLUCOSE, ANHYDROUS
D.3.9.1	CAS number	50-99-7
D.3.9.3	Other descriptive name	GLUCOSE, ANHYDROUS
D.3.9.4	EV Substance Code	SUB11988MIG
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	112.50
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

Cancer colorectal

Cancer colorrectal

E.1.1.1

Medical condition in easily understood language

Cancer colorectal

Cancer colorrectal

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10061451
E.1.2	Term	Colorectal cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main objective is to determine if perioperative nutritional support with PeriOlimel N4-E, that reaches nutritional requirements of ERAS protocol for colorectal cancer surgery patients, can improve nutritional status so it decreases postoperative complications, hospital length of stay and costs, compared to conventional fluid therapy administration since patients receive oral nutrition at day 3-5.

Valorar si la administración de soporte nutricional precoz con nutrición periférica (PeriOliclimonel N4TE) perioperatoria en pacientes operados de cáncer de colon en un Programa de Rehabilitación Multimodal (Fast track) mejoran los resultados de morbiTmortalidad e ingreso hospitalario frente a la administración de fluidoterapia convencional.

E.2.2

Secondary objectives of the trial

Not applicable

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Key Inclusion Criteria: age between 18-90 with scheduled colorectal cancer surgery and ASA I-IV.

Edad entre 18-90 años intervenidos de forma programada de cáncer colorrectal y ASA I-IV

E.4

Principal exclusion criteria

Emergency surgery, distant metastasis, patient´s refusal to participate, allergy or hypersensitivity to egg or soy protein, advanced kidney or hepatic impairment, severe bleeding disorders, congenital abnormalities of amino acid metabolism, hyperlipidemia and severe or difficult to control hyperglycemia. Relative contraindications are: hemodynamic instability, acute pulmonary edema, hypotonic dehydration and/or decompensated heart failure.

• Cirugía urgente.
• Metástasis a distancia.
• ASA > III
• Alergia o sensibilidad al huevo o proteína de soja.
• Insuficiencia renal o hepática avanzada.
• Trastorno de la coagulación grave.
• Anomalías congénitas del metabolismo de los aminoácidos.
• Hiperlipidemia e hiperglucemia graves o de dificil control.
• No aceptación o imposibilidad de seguir protocolo de rehabilitación multimodal.
• No firmar consentimiento informado.

E.5 End points

E.5.1

Primary end point(s)

We set the primary endpoint as the presence of surgical postoperative complications during the first postoperative month.

Hemos establecido el criterio principal de valoración como la presencia de complicaciones postoperatorias de cirugía durante el primer mes postoperatorio.

E.5.1.1

Timepoint(s) of evaluation of this end point

1 month

1 mes

E.5.2

Secondary end point(s)

Among secondary endpoints of the study we will record during the first month postoperative clinical and demographic variables, ASA, clinical (medical) postoperative complications, length of stay, nutritional status and an economic evaluation through a cost-utility analysis,

Entre los objetivos secundarios del estudio se van a recoger durante el primer mes postoperatorio las variables clínicas y demográficas, ASA, complicaciones médicas postoperatorias, duración de la estancia, el estado nutricional y una evaluación económica a través de un análisis de coste-utilidad.

E.5.2.1

Timepoint(s) of evaluation of this end point

1 month

1 mes

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

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

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Conventional Fluid therapy (saline 0,9% and glucose 5% solutions)

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

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

Monitoring will be performed one month after last patient is included in the study

La monitorización se realizará un mes después de que el último paciente se haya incluido en el estudio

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

180

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

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

2016-04-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-02-02

P. End of Trial
P.	End of Trial Status	Ongoing

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Orphan Designation Number:
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