Clinical Trials Register

Summary
EudraCT Number:	2009-016921-32
Sponsor's Protocol Code Number:	HSJD-OB-TRP
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-11-18
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

Spain - AEMPS

A.2

EudraCT number

2009-016921-32

A.3

Full title of the trial

A phase II, randomized, double-blind, placebo-controlled, in parallel groups clinical trial to assess the safety and efficacy of dietary supplementation with tryptophan to achieve weight loss, and its neuropsychological effects in adolescents with obesity.

Ensayo clínico de fase II, aleatorizado, con grupos paralelos, controlado con placebo y doble ciego para evaluar la seguridad y eficacia de la suplementación dietética con triptófano en la reducción del peso y sus efectos neuropsicológicos en adolescentes con obesidad

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

HSJD-OB-TRP

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	Fundació Sant Joan de Déu
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	Fondo de Investigación Sanitaria del Instituto de Salud Carlos III.
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	Fundació Sant Joan de Déu
B.5.2	Functional name of contact point	Fundació Sant Joan de Déu
B.5.3	Address:
B.5.3.1	Street Address	Fundació Sant Joan de Déu. C/Sant Rosa,39-57, 4ª planta Edificio Docente
B.5.3.2	Town/ city	Esplugas de Llobregat/Barcelona
B.5.3.3	Post code	08950
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34936009751
B.5.5	Fax number	+34936009771
B.5.6	E-mail	rmorales@fjd.org

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.3.2	Product code	TRIPTOFANO
D.3.4	Pharmaceutical form	Capsule
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	TRIPTOFANO
D.3.9.1	CAS number	73-22-3
D.3.9.3	Other descriptive name	TRYPTOPHAN
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	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.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.3.2	Product code	TRIPTOFANO
D.3.4	Pharmaceutical form	Capsule
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	TRIPTOFANO
D.3.9.1	CAS number	73-22-3
D.3.9.3	Other descriptive name	TRYPTOPHAN
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	140
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.IMP: 3
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.3.2	Product code	TRIPTOFANO
D.3.4	Pharmaceutical form	Capsule
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	TRIPTOFANO
D.3.9.1	CAS number	73-22-3
D.3.9.3	Other descriptive name	TRYPTOPHAN
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	190
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
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

obesity

Obesidad

E.1.1.1

Medical condition in easily understood language

obesity

Obesidad

E.1.1.2

Therapeutic area

Body processes [G] - Metabolic Phenomena [G03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10029883
E.1.2	Term	Obesity
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

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 efficacy of a treatment of dietary supplementation with tryptophan to achieve weight loss, and the improvement of clinical parameters such as reduced body mass index and waist/hip ratio.

Evaluar la eficacia del tratamiento dietético suplementado con triptófano en la reducción de peso, y mejoría de los parámetros clínicos como la reducción del índice de masa corporal y del índice cintura/cadera

E.2.2

Secondary objectives of the trial

1. To determine whether the administration of tryptophan as a dietary supplement helps to control intake, reducing the total number of calories consumed, and also the intake of carbohydrates throughout the day.
2. To assess the impact of tryptophan supplementation at reducing symptoms of anxiety, depression and other symptoms associated with eating disorders.
3. To determine tolerance of tryptophan as a dietary supplement in obese adolescents and its effects on plasma tryptophan levels, tryptophan/LNNAs ratio, and plasmatic serotonin.

1. Determinar si la administración de triptófano como suplemento de la dieta mejora el control de la ingesta, reduciendo el total de calorías y el consumo de hidratos de carbono al día.
2. Evaluar el impacto de la suplementación con triptófano en la reducción de los síntomas de ansiedad, depresión y síntomas asociados a los trastornos de conducta alimentaria.
3. Determinar la tolerancia del triptófano como suplemento a la dieta en adolescentes obesos y su efectos en los niveles de triptófano plasmático, ratio triptófano /LNNAs, y serotonina plasmática.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Both male and female patients, attending the Pediatric Endocrinology Service on an out-patient basis.
2. Age from 12 to 17 years, inclusively.
3. Presence of a BMI > or = to 2SD and < or = to 4SD (standard deviations) for their age and sex (Spanish cross-sectional growth reference tables of 2008)
4. Patients must have an educational level that permits adequate communication and must agree to cooperate in all the tests and examinations included in the protocol.
5. Subjects of reproductive potential must use an effective birth control method during the study. Women of reproductive age will be recruited after a negative pregnancy test.
6. The informed consent of the parents or legal representative and of the young adults is required.

1. Pacientes de ambos sexos, visitados ambulatoriamente en el Servicio de Endocrinología Infantil.
2. Edad de 12 a 17 años de edad, ambos inclusive.
3. Presencia de un IMC > ó = a 2SD y < ó = a 4SD (desviación estándar) para su edad y sexo (tablas de referencia del Estudio transversal español de crecimiento 2008)
4. Los pacientes deben tener un nivel intelectual que permita una adecuada comunicación y deberán estar de acuerdo en cooperar en todas las pruebas y exámenes requeridos en el protocolo.
5. Los sujetos con potencial reproductor realizarán un método efectivo de control de natalidad durante todo el estudio. Las mujeres en edad reproductora se incluirán tras la negatividad de la prueba de embarazo.
6. Consentimiento informado de los padres o representante legal, y asentimiento informado del menor maduro.

E.4

Principal exclusion criteria

1. Obesity secondary to an endocrine disease (hypothyroidism, Cushing?s syndrome, polycystic ovary, hypothalamic syndromes, hypogonadism) or the use of medications such as cortisol.
2. Concomitant administration of other psychotrophic medication such as antidepressants or anxiolytics.
3. Patients included in the study must not be taking any vitamins or nutritional supplements or any anti-obesity preparations, including herbal remedies, pharmacy products or homeopathic products.
4. Patients with a known psychiatric disorder.
5. Patients treated with any kind of structured psychotherapy regime.
6. Patients with type 2 DM, arterial hypertension (blood pressure above the 95 percentile for gender and height) or steatotic liver (hypertransaminasemia with echographic image of fatty liver).
7. Patients with any severe food intolerance, or with a known allergy to any of the substances used in the study.
8. Patients in treatment with oral hypoglycemiants.
9. Pregnant or breast-feeding.

1. Obesidad secundaria a una patología endocrina (hipotiroidismo, Síndrome de Cushing, ovario poliquístico, síndromes hipotalámicos, hipogonadismo) o al uso de medicamentos como el cortisol.
2. Administración concomitante de otros fármacos psicotropos como antidepresivos o ansiolíticos.
3. Los pacientes incluidos en el estudio no deben estar tomando ningún tipo de vitaminas ni complementos nutricionales, ni ningún preparado anti-obesidad ya sea de herboristería, farmacia o de homeopatía.
4. Pacientes con trastorno psiquiátrico conocido.
5. Pacientes tratados mediante cualquier tipo de psicoterapia estructurada.
6. Pacientes con DM tipo 2, hipertensión arterial (tensión arterial mayor al percentil 95 para el sexo y la talla) o hígado graso (hipertransaminasemia con imagen ecográfica de hígado graso)
7. Pacientes con intolerancia alimentaria severa, o que sufran una alergia conocida a alguno de las sustancias empleadas en el ensayo.
8. Pacientes en tratamiento con hipoglucemiantes orales.
9. Embarazo o lactancia.

E.5 End points

E.5.1

Primary end point(s)

The following clinical variables will be studied: weight, height, BMI, weight/height Z-scores, BMI Z-score, and height/blood pressure and waist/hip circumference Z-scores.

Se estudiarán las siguientes variables clínicas: peso, talla, IMC, z peso/talla, z IMC y Z talla/ edad tensión arterial y circunferencia de cintura y cadera.

E.5.1.1

Timepoint(s) of evaluation of this end point

These parameters will be measured before starting the study and every month for the following six months.

Serán medidas antes de comenzar el tratamiento y posteriormente cada mes durante 6 meses.

E.5.2

Secondary end point(s)

See protocol (variables associated with secondary objectives).

Ver en el protocolo (Variables relacionadas con los objetivos secundarios)

E.5.2.1

Timepoint(s) of evaluation of this end point

See protocol (variables associated with secondary objectives).

Ver en el protocolo (Variables relacionadas con los objetivos secundarios)

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)

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)

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.8.5

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

Six months after the start of treatment.

Al cabo de 6 meses de iniciado el tratamiento

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:

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)

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

Information not present in EudraCT

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

Not applicable.

No aplica

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

2011-07-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

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

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