Clinical Trials Register

Summary
EudraCT Number:	2012-004293-26
Sponsor's Protocol Code Number:	QTM/GEP0512
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:	2012-10-29
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

2012-004293-26

A.3

Full title of the trial

Multisite, open, randomized, parallel and controlled clinical trial, to evaluate the efficacy and safety of a laxative fiber formula compared to Plantaben on objective and subjective parameters of the occasional constipation

Estudio clínico multicéntrico, aleatorizado, abierto, paralelo y controlado para evaluar la eficacia y seguridad de una fórmula laxante fibra frente a Plantaben sobre parámetros objetivos y subjetivos del estreñimiento ocasional

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

QTM/GEP0512

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	GeiserPHARMA SL
B.1.3.4	Country	Spain
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	GeiserPHARMA SL
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	GeiserPHARMA SL
B.5.2	Functional name of contact point	Tamara Cordero
B.5.3	Address:
B.5.3.1	Street Address	Camino Labiano, 45B
B.5.3.2	Town/ city	Navarra
B.5.3.3	Post code	31192
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034948101943
B.5.5	Fax number	0034948229090
B.5.6	E-mail	tcordero@geiserpharma.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	LAXANTE FIBRA
D.3.4	Pharmaceutical form	Powder and solvent for oral suspension
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	Plantago ovata seed coat
D.3.9.3	Other descriptive name	PLANTAGO OVATA SEED COAT
D.3.9.4	EV Substance Code	SUB35062
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	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RHAMNUS FRANGULA L. CORTEX
D.3.9.3	Other descriptive name	RHAMNUS FRANGULA L. CORTEX
D.3.9.4	EV Substance Code	SUB11976MIG
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	38
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	Yes
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	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	Plantaben
D.2.1.1.2	Name of the Marketing Authorisation holder	ROTTAPHARM, S.L.
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	Plantaben
D.3.2	Product code	Plantaben
D.3.4	Pharmaceutical form	Effervescent powder
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	PLANTAGO OVATA SEED COAT
D.3.9.3	Other descriptive name	PLANTAGO OVATA SEED COAT
D.3.9.4	EV Substance Code	SUB35062
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	3.5
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	Yes
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	Fave de Fuca
D.2.1.1.2	Name of the Marketing Authorisation holder	Uriach Aquilea Otc, S.L.
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	Fave de Fuca
D.3.2	Product code	Fave de Fuca
D.3.4	Pharmaceutical form	Coated tablet
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	RHAMNUS FRANGULA L. CORTEX
D.3.9.3	Other descriptive name	RHAMNUS FRANGULA L. CORTEX
D.3.9.4	EV Substance Code	SUB11976MIG
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	222
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FRANGULA PURSHIANA BARK
D.3.9.3	Other descriptive name	FRANGULA PURSHIANA BARK
D.3.9.4	EV Substance Code	SUB34042
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	170
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FUCUS VESICULOSUS L. (TALOS)
D.3.9.3	Other descriptive name	FUCUS VESICULOSUS L. (TALOS)
D.3.9.4	EV Substance Code	SUB88885
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	126
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	Yes
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

Occasional constipation

Estreñimiento ocasional

E.1.1.1

Medical condition in easily understood language

Occasional constipation

Estreñimiento ocasional

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	PT
E.1.2	Classification code	10010774
E.1.2	Term	Constipation
E.1.2	System Organ Class	10017947 - Gastrointestinal 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 compare the efficacy of 2 formulations in terms of weekly stools production in patients with occasional constipation

Comparar la eficacia de dos formulaciones en cuanto a producción semanal de deposiciones, en pacientes con estreñimiento ocasional.

E.2.2

Secondary objectives of the trial

- To evaluate the quality of the stools
- To evaluate the organoleptic and acceptability properties and subjective efficacy of the product.
- To evaluate the safety of a laxative formula fibre

- Evaluar la calidad de las deposiciones.
- Evaluar las propiedades organolépticas y de aceptabilidad y eficacia subjetiva del producto.
- Evaluar la seguridad de la formulación en estudio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subjects of both sexes (men or women).
2. Between the ages of 18 and 60 years.
3. Occasional constipation, since 6 weeks ago
4. Appropriate cultural level and understanding of the clinical trial.
5. Agree to participate voluntarily in the clinical trial and give their informed consent in writing
6. Not treated for constipation (medication or nutritional supplement) in a period of 7 days before the treatment

1. Sujetos de ambos sexos (hombres o mujeres).
2. Edad comprendida entre los 18 y los 60 años.
3. Presentar estreñimiento ocasional, desde no más de 6 semanas.
4. Adecuado nivel cultural y de comprensión del ensayo clínico.
5. Estar de acuerdo en participar voluntariamente en el ensayo clínico y que den su consentimiento informado por escrito
6. No tratados para el estreñimiento (medicamento o complemento nutricional) en un plazo de 7 días previos al tratamiento

E.4

Principal exclusion criteria

1. Pregnancy and lactation
2. Be taking other laxatives
3. Functional constipation (according to criteria Rome III)
4. Gastrointestinal diseases severe acute in a prior period of 3 months to the participation in the clinical trial, or suffering from chronic gastrointestinal illnesses such as (intestinal obstruction, stenosis of the tract di gestivo, fecal impaction, atony of colon, ileus, abdominal pain, nausea or vomiting, diabetes mellitus difficult to regulate, undiagnosed rectal bleeding, inability to have a bowel movement after use of a laxative, patients with diseases of the esophagus, as Barrett's Esophagus and gastro-oesophageal reflux...)
5. Subjects with allergy or hypersensitivity to any component of the product under study (excipients or API)
6. Patients with swallowing difficulty.
7. To present acetyl salicylic acid allergy
8. To present situation of 'immobility' and previous episodes of 'faecal impaction'

1. Embarazo y lactancia
2. Estar tomando otros laxantes
3. Sujetos cuyo estreñimiento ocasional esté asociado a la toma de medicamentos.
4. Pesentar estreñimiento funcional o crónico (según criterios Roma III)
5. Enfermedades gastrointestinales graves agudas en un periodo previo de 3 meses a la participación en el ensayo clínico, o padecer de enfermedades gastrointestinales crónicas, como por ejemplo ( Obstrucción intestinal,estenosis del tracto di¡gestivo, impactación fecal,atonia del colon,ileo, dolor abdominal,nauseas o vomitos, diabetesmellitus dificil de regular, sangrado rectal no diagnosticado, imposibilidad de defecar despues de utilizar un laxante, pacientes con enfermedades del esófago, como Esofago de Barrett y reflujo gastroesofágico)
6. Sujetos con alergia o hipersensibilidad a alguno de los componentes del producto en estudio (excipientes o API)
7. Pacientes con dificultad al tragar.
8. Presentar alergia al ácido acetil salicilico
9. Presentar situación de "inmovilidad" y episodios previos de "impactación fecal"

E.5 End points

E.5.1

Primary end point(s)

Number of weekly stools (weekly stools production)

Número de deposiciones/semana (producción semanal de deposiciones)

E.5.1.1

Timepoint(s) of evaluation of this end point

7 days

7 días

E.5.2

Secondary end point(s)

- The time that it takes to achieve a pharmacological effect. (the time that it takes to go from <3 weekly stools to >3.5weekly stools)
- Quality of stools (number and consitency) according to Bristol scale
- Evaluation of the organoleptic and acceptability properties and subjective efficacy, through the satisfaction survey.
Score from 0 to 4 of each of the items proposed in the survey
-Presence of pain associated with defecation (through analysis of visual analog scale).
- Assessment of the adverse events

- Tiempo que se tarda en lograr un efecto farmacológico. (tiempo que se tarda en pasar de <3 deposiciones semanales a >3.5)
- Calidad (número y consistencia) de las deposiciones, según la escala de Bristol
- Evaluación de las propiedades organolépticas y de aceptabilidad y eficacia subjetiva, a través de la encuesta de satisfacción.
Puntuación de 0 a 4 de cada uno de los ítems propuestos en la encuesta
- Presencia de dolor asociado a la defecación (a través de análisis de escala analógica visual).
- Evaluación de los Acontecimientos Adversos

E.5.2.1

Timepoint(s) of evaluation of this end point

7 days

7 días

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)

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

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

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

LVLS (última visita del último paciente)

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:

150

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

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

2013-09-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-14

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

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