Clinical Trials Register

Summary
EudraCT Number:	2008-004610-27
Sponsor's Protocol Code Number:	CR-IBD-1-08
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:	2008-09-26
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

2008-004610-27

A.3

Full title of the trial

Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.

A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis

A.4.1

Sponsor's protocol code number

CR-IBD-1-08

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Palau Pharma S.A.
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Dersalazina sodica
D.3.4	Pharmaceutical form	Capsule*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	dersalazine sodium
D.3.9.1	CAS number	367249-56-7
D.3.9.2	Current sponsor code	UR-12746-S
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	400
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Information not present in EudraCT
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	LIXACOL
D.2.1.1.2	Name of the Marketing Authorisation holder	FAES FARMA, S.A.
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	LIXACOL
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	MESALAZINA
D.3.9.1	CAS number	89-57-6
D.3.9.3	Other descriptive name	MESALAZINE
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	400
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Information not present in EudraCT
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	LIXACOL
D.2.1.1.2	Name of the Marketing Authorisation holder	FAES FARMA, S.A.
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	LIXACOL
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	MESALAZINA
D.3.9.1	CAS number	89-57-6
D.3.9.3	Other descriptive name	MESALAZINE
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	400
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Information not present in EudraCT

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
D.8 Placebo: 2
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

Colitis ulcerosa de leve a moderada
Mild to moderate ulcerative colitis

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10045365
E.1.2	Term	Ulcerative colitis

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

El objetivo principal de este estudio es obtener una primera prueba de seguridad clínica de dersalazina sódica a dosis de 1200 mg administrada dos veces al día durante 28 días en pacientes con CU activa leve a moderada en comparación con placebo y un estándar de referencia activo, mesalazina 1200 mg administrada dos veces al día durante 28 días.

E.2.2

Secondary objectives of the trial

- Obtener una valoración de la exposición a dersalazina y sus metabolitos (UR-12715, 5-ASA y N-acetil-5-ASA) en pacientes con CU activa leve a moderada después de una administración oral repetida de 1200 mg dos veces al día durante 28 días, mediante la valoración de valores valle pre dosis y valores pico post dosis.
- Explorar la eficacia de dersalazina sódica a dosis de 1200 mg administradas dos veces al día en pacientes con colitis ulcerosa leve o moderada, comparado con placebo y un activo estándar de referencia (mesalazina).

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Titulo: “Estudio de biomarcadores en colitis ulcerosa”. Fecha: Mayo 2008 (borrador del protocolo). Objetivos:
1.Identificar un conjunto de parámetros biológicos que pueden ser usados en ensayos clínicos futuros como marcadores de cambios clínicamente relevantes en actividad inflamatoria en pacientes con CU activa leve a moderada.
2. Valorar el efecto de dersalazina sódica a dosis de 1200 mg administrados dos veces al día durante 28 días sobre un conjunto de marcadores biológicos de actividad

E.3

Principal inclusion criteria

1.Tener entre 18 y 65 años (inclusive).
2.Ser hombre o bien si se trata de una mujer deberá cumplir los requisitos siguientes:
-Mujer infértil (incapaz de quedar embarazada, bien porque ha sido esterilizada o bien porque es post-menopáusica (1 año sin la regla).
O bien
-Mujer fértil con las siguientes restricciones:
-Todas las mujeres fértiles deberán tener un test sanguíneo de embarazo negativo en el momento de la selección y aleatorización.
-Todas las mujeres fértiles, si son heterosexualmente activas, deberán usar una de las formas aceptadas de contracepción durante todo el estudio y al menos un ciclo mensual después de la finalización del mismo. Las formas aceptadas de contracepción se definen como cualquier contraceptivo hormonal (iniciado al menos 2 meses antes del inicio del estudio), uso de un dispositivo intrauterino (establecido antes del inicio del estudio) o bien esterilización masculina más el uso por, al menos uno de los miembros de la pareja, de un método de contracepción de barrera con espermicida (preservativo o diafragma). El uso de un solo método de contracepción o abstinencia no se considera adecuado.
3.Tener un diagnóstico de colitis ulcerosa confirmado con endoscopia al menos 3 meses antes de la entrada del paciente en el estudio.
4.La enfermedad se extiende como mínimo 20 cm más allá del recto en la evaluación endoscópica de selección.
5.Tener colitis ulcerosa activa definida como un resultado en el índice de Mayo entre 5 y 10 ambos inclusive en la visita de selección.
6.Tener un resultado en el sub-índice de endoscopia menor o igual a 2 en el índice de Mayo calculado en la visita de selección.
7.Capaz de comunicarse con el investigador y el personal investigador y de cumplir con los requisitos del estudio.
8.Capaz de dar consentimiento informado por escrito.

E.4

Principal exclusion criteria

1. El paciente presenta alguna condición médica o psiquiátrica que, en opinión del investigador, impide la participación en el estudio.
2. El paciente tiene una historia de alergia o intolerancia a la aspirina, mesalazina u otros salicilatos.
3. El paciente presenta un cultivo fecal positivo que indica la presencia de una infección patógena.
4. El paciente ha recibido tratamiento con inmunosupresores (azatioprina, ciclosporina o mercaptopurina) durante los 90 días previos a la visita de selección.
5. El paciente ha recibido metotrexato durante los 90 días previos a la visita de selección.
6. El paciente ha recibido corticosteroides (orales, endovenosos o tópicos por vía rectal) durante los 30 días previos a la visita de selección. (Otros tratamientos tópicos o inhalados son permitidos).
7. El paciente ha recibido tratamiento con terapia biológica (infliximab, adalimumab, o natalizumab) durante los 90 días previos a la visita de selección.
8. El paciente ha recibido aminosalicilatos por vía rectal durante los 14 días previos a la visita de selección.
9. El paciente ha recibido tratamiento repetido (más de 3 días) con antiinflamatorios no esteroideos durante los 14 días previos a la visita de selección.
10. El paciente ha recibido antibióticos durante los 14 días previos a la visita de selección.
11. La paciente está embarazada, con potencial riesgo de estar embarazada o bien está lactando.
12. El paciente muestra evidencias de un consumo excesivo de alcohol o drogas según el criterio del investigador.
13. El paciente es incapaz de dar su consentimiento informado.
14. Se sabe que el paciente es positivo para hepatitis B, C o VIH.
15. El paciente presenta alguna otra enfermedad infecciosa, isquémica o inmunológica.
16. El paciente presenta valores de alanina aminotransferasa (ALT/GOT), gamma glutamil transferasa (GGT), aspartato aminotransferasa (AST/GPT), fosfatas alcalina (ALP) o bilirrubina total (excepto elevaciones puntuales de bilirrubina no conjugada) iguales o mayores a 2XULN.
17. El paciente presenta una insuficiencia renal no controlada caracterizada por valores iguales o superiores a 2XULN para creatinina sérica o nitrógeno ureico en sangre (BUN).
18. El paciente presenta una enfermedad cardiovascular inestable (coagulopatía o enfermedad tromboembólica pulmonar Clase III & IV según NYHA).
19. El paciente presenta alguna condición o circunstancia que, en opinión del investigador impide la realización del estudio o interfiere con el análisis de los resultados del mismo, incluyendo antecedentes de no cumplimiento con tratamientos o visitas.

E.5 End points

E.5.1

Primary end point(s)

El criterio primario de seguridad será la proporción de pacientes con EA de intensidad grave o EAs que motivan el abandono del tratamiento en cada uno de los grupos de tratamiento

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

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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.8.3

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

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

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

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

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

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

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)

Per protocol

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

2008-11-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-11-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-05-17

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