Clinical Trials Register

Summary
EudraCT Number:	2006-004291-12
Sponsor's Protocol Code Number:	101.1.C.004
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:	2007-03-20
Trial results	View 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

2006-004291-12

A.3

Full title of the trial

ESTUDIO MULTINACIONAL, MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO Y DE GRUPOS PARALELOS PARA COMPARAR LA SEGURIDAD Y LA EFICACIA DE 200 mg DE PAR-101 CADA 12 HORAS CON 125 mg DE VANCOMICINA CADA 6 HORAS DURANTE DIEZ DÍAS EN SUJETOS CON DIARREA ASOCIADA A CLOSTRIDIUM DIFFICILE

A multi-national, multi-centre, double-blind, randomised, parallel group study to compare the safety and efficacy of 200mg PAR-101 taken q12h with 125mg Vancomycin taken q6h for ten days in subjects with Clostridium Difficile-associated diarrhea

A.3.2

Name or abbreviated title of the trial where available

A double−blind, randomised study of PAR−101 vs vancomycin in CDAD

A.4.1

Sponsor's protocol code number

101.1.C.004

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	Par Pharmaceutical, Inc.
B.1.3.4	Country	United States
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
B.Sponsor: 2
B.1.1	Name of Sponsor	Optimer Pharmaceuticals, Inc.
B.1.3.4	Country	United States
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	PAR-101/OPT-80
D.3.2	Product code	PAR-101/OPT-80
D.3.4	Pharmaceutical form	Capsule, hard
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.3.9.1	CAS number	873857-62-6
D.3.9.2	Current sponsor code	PAR-101/OPT-80
D.3.9.3	Other descriptive name	diffimicin
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	200
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)	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	Yes
D.3.11.13.1	Other medicinal product type	Antibiotic
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	Vancocin
D.2.1.1.2	Name of the Marketing Authorisation holder	ViroPharma (US)
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Vancomycin
D.3.2	Product code	Vancomycin
D.3.4	Pharmaceutical form	Capsule, hard
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	VANCOMYCIN
D.3.9.1	CAS number	1404906
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	125
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)	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	Yes
D.3.11.13.1	Other medicinal product type	Antibiotic

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, hard
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

DIARREA ASOCIADA A CLOSTRIDIUM DIFFICILE
Clostridium difficile associated diarrhoea (CDAD)

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	8.1
E.1.2	Level	LLT
E.1.2	Classification code	10012748
E.1.2	Term	Diarrhoea, Clostridium difficile

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Demostrar que el índice de curación de la diarrea asociada a Clostridium difficile tras el tratamiento con PAR-101 no es peor que el índice de curación tras el tratamiento con vancomicina,

Evaluar la seguridad y tolerabilidad de PAR-101 en sujetos con diarrea asociada a Clostridium difficile.

E.2.2

Secondary objectives of the trial

Demostrar que el índice de recidiva de la diarrea asociada a Clostridium difficile tras el tratamiento con PAR-101 no es peor que el índice de recidiva tras el tratamiento con vancomicina.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Hombres o mujeres hospitalizados/ambulatorios de 16 años o mayores con diarrea asociada a Clostridium difficile conforme a las siguientes definiciones:
• Diarrea: se define como un cambio en los hábitos de defecación, con >3 deposiciones blandas en las 24 horas anteriores a la aleatorización, y
•Presencia de toxina A o B de C. difficile en las heces en 48 horas de la aleatorización.

2. Las mujeres en edad fértil deberán utilizar un método anticonceptivo adecuado y fiable (p. ej.: barrera con espuma o gel espermicida adicional, dispositivo intrauterino, anticonceptivos hormonales). Las mujeres posmenopáusicas deberán llevar posmenopáusicas ≥1 año. Los sujetos (tanto hombres como mujeres) deberán estar de acuerdo en evitar el embarazo durante el tratamiento y durante cuatro semanas tras finalizar el tratamiento del estudio.

3. Todos los sujetos tendrán que firmar un documento de consentimiento informado.

4. Los opiáceos estarán permitidos siempre que el sujeto tome una dosis estable en el momento de la aleatorización y se espere que mantenga esta dosis durante el período de tratamiento.
• Los opiáceos a demanda están permitidos siempre que la dosis total diaria no cambie durante el período de tratamiento.

5. Los sujetos que hayan fracasado con al menos un ciclo completo de 3 días de metronidazol pero que sigan satisfaciendo la definición de diarrea sin ninguna mejoría clínica significativa y permanezcan positivos para toxinas podrán inscribirse en el estudio.

E.4

Principal exclusion criteria

1. Diarrea asociada a Clostridium difficile potencialmente mortal o fulminante (leucocitos >30 x 109/l; temperatura >40°C; o indicios de hipotensión [tensión arterial sistólica inferior a 90 mm Hg], y choque septicémico, signos peritoneales o deshidratación significativa).

2. Megacolon tóxico.

3. Exposición previa a PAR-101.

4. Mujeres embarazadas o en período de lactancia.

5. Probabilidad de fallecimiento en el plazo de 72 horas por cualquier causa.

6. Uso concurrente de: vancomicina por vía oral, metronidazol, bacitracina por vía oral, ácido fusídico, rifaximina, nitazoxanida o medicamentos relacionados. Si el investigador lo considera clínicamente imperativo comenzar el tratamiento antes de saber el resultado de laboratorio para toxinas en heces, se permitirán hasta 4 dosis, pero no más de 24 horas de tratamiento con metronidazol y/o vancomicina. Aunque los sujetos previamente tratados podrán inscribirse (es decir, no más de 24 horas de terapia previa), es preferible incluir a sujetos que no hayan recibido tratamiento previo para la diarrea asociada a Clostridium difficile en esta inclusión. Siempre que sea posible, se recomienda que los investigadores identifiquen a los sujetos elegibles antes de la administración de otras terapias y que “sensibilicen” a su centro en relación con este estudio para poder inscribir a sujetos sin terapia previa.

7. Necesidad prevista de continuar otros antibacterianos durante un período superior a siete días a partir del comienzo del estudio.

8. Los sujetos que en opinión del investigador requieran otros medicamentos para controlar la diarrea (por ej.: loperamida) o que puedan afectar al peristaltismo.

9. No puede o no quiere cumplir con el protocolo del estudio, incluyendo ingesta de cápsulas, extracciones de sangre o proporcionar una muestra de heces conforme al programa.

10. Participación en otros estudios de investigación clínica utilizando un agente en fase de investigación en el mes anterior a la selección o en cinco semividas del agente en fase de investigación, cualquiera que sea el período más largo.

11. Historia de colitis ulcerosa o enfermedad de Crohn.

12. Episodios múltiples (definidos como más de un episodio anterior) de diarrea asociada a Clostridium difficile en los últimos tres meses. Los sujetos que acudan con la primera recidiva en los últimos 3 meses podrán inscribirse.

13. No se incluirá a los sujetos que el investigador cree inapropiados para el ensayo, p. ej.: sujetos con hipersensibilidad conocida a la vancomicina.

E.5 End points

E.5.1

Primary end point(s)

Índices principales de curación (respuesta principal) en las poblaciones microbiológicamente evaluable y con intención de tratamiento modificada (mITT)

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

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

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)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

vancomycin

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

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

Last post-dose visit (days 36-40) of the last subject.

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 months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	Yes
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	Yes
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	60
F.4.2	For a multinational trial
F.4.2.1	In the EEA	332
F.4.2.2	In the whole clinical trial	664

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

2007-07-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-04-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-12-11

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials