Clinical Trials Register

Summary
EudraCT Number:	2015-004391-29
Sponsor's Protocol Code Number:	InBoTox
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:	2016-02-03
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

2015-004391-29

A.3

Full title of the trial

Effectiveness of intragastric injection of botulinum toxin by endoscopy in obese patients in surgical waiting list. Study InBoTox

Eficacia de la inyección intragástrica de toxina botulínica mediante endoscopia en pacientes obesos en lista de espera quirúrgica. Estudio InBoTox

A.3.1

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

Effectiveness of intragastric injection of botulinum toxin obese patients

Eficacia de la inyección intragástrica de toxina botulínica en pacientes obesos

A.3.2

Name or abbreviated title of the trial where available

InBoTox

A.4.1

Sponsor's protocol code number

InBoTox

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	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
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	FIMABIS
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	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
B.5.2	Functional name of contact point	Gloria Luque-Fernandez
B.5.3	Address:
B.5.3.1	Street Address	Avda Carlos Haya s/n
B.5.3.2	Town/ city	Malaga
B.5.3.3	Post code	29010
B.5.3.4	Country	Spain
B.5.4	Telephone number	34951291977
B.5.5	Fax number	34951440263
B.5.6	E-mail	gloria.luque@fimabis.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	Yes
D.2.1.1.1	Trade name	BOTOX
D.2.1.1.2	Name of the Marketing Authorisation holder	Allergan
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.3.1	Product name	botulinum toxin
D.3.2	Product code	93384-43-1
D.3.4	Pharmaceutical form	Powder for concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraduodenal use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CLOSTRIDIUM BOTULINUM TOXIN TYPE A
D.3.9.1	CAS number	93384-43-1
D.3.9.2	Current sponsor code	63.194
D.3.9.3	Other descriptive name	BOTULINUM TOXIN TYPE A
D.3.9.4	EV Substance Code	SUB32712
D.3.10	Strength
D.3.10.1	Concentration unit	U unit(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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Solution for infusion
D.8.4	Route of administration of the placebo	Intraduodenal use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Morbid obesity

Obesidad mórbida

E.1.1.1

Medical condition in easily understood language

Obesity

Obesidad

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

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 determine the effect of intragastric toxin on weight loss in obese patients before bariatric surgery.

Determinar el efecto de la toxina botulínica intragástrica sobre la pérdida de peso en paciente obesos previa a la intervención de cirugía bariátrica.

E.2.2

Secondary objectives of the trial

- To identify the presence of gastrointestinal symptoms de novo with the performance of the technique.
- To compare other anthropometric values between treatment group and control group.
- To check level differences between postprandial satiety treatment group and control group.
- To compare caloric intake between treatment group and control group.
- To compare levels of mediators of appetite and satiety between treatment group and control group.
- To identify possible variations in quality of life between treatment group and control group.

- Identificar la presencia de sintomatología gastrointestinal de novo con la realización de la técnica.
- Comparar otros valores antropométricos entre grupo tratamiento y grupo control.
- Comprobar diferencias a nivel de saciedad postprandial entre grupo tratamiento y grupo control.
- Comparar ingesta calórica entre grupo tratamiento y grupo control.
- Comparar niveles de mediadores del apetito y saciedad entre grupo tratamiento y grupo control.
- Identificar posibles variaciones en la calidad de vida entre grupo tratamiento y grupo control.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female
2. Age 18-65 years
3. BMI> 40 or BMI> 35 with comorbidities
4. Waiting list for bariatric surgery between 6 and 12 months before the intervention.
5. Willingness to attend scheduled visits

1. Ambos géneros
2. Edad entre 18-65 años
3. IMC>40 o IMC>35 con comorbilidades
4. Lista de espera para cirugía bariátrica, entre 6 y 12 meses antes de la intervención.
5. Disponibilidad para acudir a consultas programadas

E.4

Principal exclusion criteria

1. Obesity of endocrine origin.
2. Recent anti-obesity 2 treatment (<3 months).
3. myopathy, known neuromuscular or neurological disease
4. Severe Psychopathology contraindicating procedure
5. active gastrointestinal disease (esophagitis, peptic ulcer, cancer, etc., already diagnosed).
6. History of gastric surgery.
7. previous botulism.
8. dysfunction of gastrointestinal motility because of opioids, anticholinergics or other drugs.
9. known intolerance upper endoscopy.
10. Pregnant or breast-feeding.

1. Obesidad de origen endocrino.
2. Tratamiento anti-obesidad reciente (<3 meses).
3. Miopatía, enfermedad neuromuscular o neurológica conocida.
4. Psicopatología grave que contraindique el procedimiento
5. Enfermedad gastrointestinal activa (esofagitis, ulcera péptica, cáncer, etc, diagnosticados por endoscopia).
6. Historia de cirugía gástrica.
7. Botulismo previo.
8. Disfunción de la motilidad gastrointestinal por opioides, anticolinérgicos u otros fármacos.
9. Intolerancia conocida a endoscopia alta.
10. Embarazadas o en lactancia.

E.5 End points

E.5.1

Primary end point(s)

To determine the effect of intragastric toxin on weight loss in obese patients before bariatric surgery.

Determinar el efecto de la toxina botulínica intragástrica sobre la pérdida de peso en paciente obesos previa a la intervención de cirugía bariátrica.

E.5.1.1

Timepoint(s) of evaluation of this end point

After 2, 4, 8, 16 and 24 weeks

A las 2, 4, 8, 16 y 24 semanas

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

After 2, 8 and 24 weeks

A las 2, 8 y 24 semanas

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)

Yes

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

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: visit at week 24.
The patient can leave before the last visit because:
- Remove informed consent to participate in the activities of the clinical trial.
- Abandon the revisions, making it impossible for location or reuptake.
- Dies.
He/she will be given the best treatment available

LVLS: visita de la semana 24
El paciente puede abandonar antes el ensayo por:
- Retira su consentimiento previo para participar en las actividades del EC.
- Abandona las revisiones, siendo imposible su localización o recaptación.
- Fallece.
Se le administrará el mejor tratamiento disponible

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)

Yes

F.1.2.1

Number of subjects for this age range:

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

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

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

Ninguno

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

2016-04-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-02

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

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