Clinical Trials Register

Summary
EudraCT Number:	2011-004770-28
Sponsor's Protocol Code Number:	ST261-DM-11-006
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:	2012-01-11
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2011-004770-28

A.3

Full title of the trial

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment.

Estudio de Fase III, de grupos paralelos, controlado con placebo, doble ciego, aleatorizado, multicéntrico, internacional, para investigar la seguridad y eficacia de los comprimidos de liberación modificada de propionil-L-carnitina clorhidrato (ST 261) en pacientes afectados por colitis ulcerosa leve bajo tratamiento oral estable

A.3.1

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

Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates

Investigación de los efectos secundarios potenciales y los efectos en el intestino grueso de la propionil-L-carnitina clorhidrato (ST 261) (como comprimidos que liberan el principio activo sólo en el intestino grueso) en pacientes con colitis ulcerosa leve que son tratados de forma concomitante con una dosis estable de aminosalicilatos

A.3.2

Name or abbreviated title of the trial where available

Propionyl-L-Carnitine in Ulcerative Colitis

Propionil-L-Carnitina en Colitis Ulcerosa

A.4.1

Sponsor's protocol code number

ST261-DM-11-006

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	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
B.1.3.4	Country	Italy
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	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
B.5.2	Functional name of contact point	Carla Cucco
B.5.3	Address:
B.5.3.1	Street Address	Viale Shakespeare, 47
B.5.3.2	Town/ city	Rome
B.5.3.3	Post code	00144
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39-06-91394322
B.5.5	Fax number	+39-06-91166976
B.5.6	E-mail	carla.cucco@sigma-tau.it

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	PROPIONYL L-CARNITINE
D.3.2	Product code	ST 261
D.3.4	Pharmaceutical form	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	Levocarnitine propyl hydrochloride
D.3.9.1	CAS number	119793-66-7
D.3.9.2	Current sponsor code	(ST261) Propionyl-L-carnitine hydrochloride
D.3.9.3	Other descriptive name	(R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	500
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	Tablet
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

Mild ulcerative colitis

Colitis ulcerosa leve

E.1.1.1

Medical condition in easily understood language

Mild non-infectious inflammation of the large bowel

Inflamación no infecciosa leve del intestino grueso

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10066678
E.1.2	Term	Acute ulcerative colitis
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

Compare the two treatment groups (ST 261 modified release
tablets 1g/die vs. placebo) with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment
Evaluation of safety and tolerability of ST 261

Comparar los dos grupos de tratamiento (comprimidos de liberación modificada de ST 261 1 g/día frente a placebo) con respecto a la proporción de pacientes con remisión de la enfermedad al final de las 8 semanas de tratamiento.
La evaluación de la seguridad y tolerabilidad de ST 261 también es un objetivo principal del estudio.

E.2.2

Secondary objectives of the trial

Maintenance of remission after four weeks of treatment interruption, the histological changes, the disease symptoms (sub-scores) improvement and the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ).

Mantenimiento de la remisión después de cuatro semanas de interrupción del tratamiento, los cambios histológicos, la mejoría en los síntomas de la enfermedad (puntuaciones) y la calidad de vida general medida por el Breve cuestionario de la Enfermedad Inflamatoria Intestinal (SIBDQ).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Have read the Information for the Patient and signed the Informed Consent Form.
2. Age comprised between 18 and 75 included.
3. Diagnosis of active ulcerative colitis since at least 4 weeks as confirmed endoscopically (pancolonoscopy) and histologically. A new pancolonoscopy is required if documented evidence of having performed it within the previous 12 months is not available. If available, only a new colonoscopy for the visualization of the affected part of the colon is required for the evaluation of the baseline DAI score.
4. Disease Activity Index comprised between 3 and 6, inclusive (mild ulcerative colitis), with rectal bleeding sub-score of at least 1.
5. Stable background oral aminosalycilates (mesalazine, balsalazide, olsalazine) or sulfasalazine standard therapy for greater than or equal to 4 weeks prior to screening assessments.
6. If female, not pregnant or nursing.
7. For women of childbearing potential (WOCBP), willingness to avoid a pregnancy during the treatment period and for at least 4 weeks from the last dose of drug. A WOCBP is defined as any female who has experienced menarche and who has not ndergone
successful surgical sterilisation (hysterectomy, bilateral tubal ligation or bilateral ovariectomy) or is not postmenopausal (defined as amenorrhoea >12 consecutive months). WOCBP should use an efficient method of birth control for the entire duration of the trial and until the first menses after a 30-day period after the last dose of trial medication. They must be
on a stable regimen, for at least 1 month, of oral contraceptives, contraceptive implant or depot injection, contraceptive patch, intrauterine device (IUD), condom and spermicidal agent, or
diaphragm and spermicidal agent. The patient will be informed about the
result of the pregnancy test and of the allowed method of contraception
and its duration

1. Hayan leído la Información para el paciente y hayan firmado el Formulario de consentimiento informado.
2. Tengan una edad comprendida entre los 18 y los 75 años, ambos inclusive.
3. Tengan diagnóstico de colitis ulcerosa activa desde hace al menos 4 semanas, confirmada endoscópicamente (pancolonoscopia) e histológicamente. Será necesaria una nueva pancolonoscopia si no se dispone de pruebas documentadas que evidencien que se ha realizado en los 12 meses anteriores. Si está disponible, se requerirá solo una nueva colonoscopia para visualizar la parte afectada del colon con el fin de evaluar el valor inicial de la puntuación del IAE.
4. Un Índice de Actividad de la Enfermedad comprendido entre 3 y 6, ambos inclusive (colitis ulcerosa leve) con una puntuación de hemorragia rectal de al menos 1.
5. Aminosalicilatos orales de fondo estables (mesalazina, balsalazida, olsalazina) o tratamientos estándar con sulfasalazina durante 4 semanas o más antes de las evaluaciones de selección.
6. Si son mujeres, no estar embarazadas ni en período de lactancia.
7. En el caso de las mujeres en edad fértil (MEF), disposición para evitar el embarazo durante el período de tratamiento y durante al menos 4 semanas después de la última dosis del fármaco.
Una MEF se define como cualquier mujer que haya experimentado menarquia y que no se haya sometido a una esterilización quirúrgica con éxito (histerectomía, ligadura bilateral de trompas u ovariectomía bilateral) o que no sea postmenopáusica (definida como amenorrea > 12 meses consecutivos).
Las MEF debe usar un método anticonceptivo eficaz durante todo el ensayo y hasta las primeras menstruaciones tras un período de 30 días posterior a la última dosis de la medicación del ensayo. Deben estar recibiendo una pauta estable, durante al menos 1 mes, de anticonceptivos orales, implante anticonceptivo o inyección depot, parche anticonceptivo, dispositivo intrauterino (DIU), preservativo y agente espermicida, o diafragma y agente espermicida.Se informará a la paciente del resultado de la prueba del embarazo y de cuáles son los anticonceptivos permitidos y cuándo es obligatorio utilizarlos.

E.4

Principal exclusion criteria

1. Crohn?s disease and indeterminate colitis.
2. Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids.
3. Use of systemic antibiotics in the last 10 days preceding the screening.
4. Use of systemic NSAIDs on a repeat basis in the last 10 days preceding the screening.
5. Use of probiotics started within 10 days preceding the screening. A stable regimen from at least 10 days prior to screening is allowed but the patient must be willing to continue up to the end of the study.
6. Use of immunosuppressants or biological agents within the last 6 weeks preceding the screening.
7. Stool culture positive for enteric pathogens (eg, Shigella, Salmonella, Yersinia, Campylobacter) or toxins (C.difficile).
8. Significantly impaired liver, renal, pulmonary or cardiovascular function as assessed by the investigator.
9. History of colon resection.
10. Diverticulitis, symptomatic diverticulosis.
11. Active peptic ulcer disease.
12. Proctitis (extent of inflammation <15 cm from the anus).
13. Bleeding disorders
14. Rectal therapy with any therapeutic enemas or suppositories with the exception of those required for endoscopy during the 10 days preceding the screening.
15. Active or chronic infection(s) or malignancies.
16. Known hypersensitivity to the active ingredient and excipients of the study drug.
17. Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrolment into the present study.
18. Any physical or psychological condition in a patient that could let the investigator suspect his/her poor compliance.
19. Patients treated with L-carnitine or its ester derivates during the three months preceding the screening.

1. Enfermedad de Crohn y colitis indeterminada.
2. Uso actual o anterior (en los 10 últimos días anteriores a la selección) de corticoesteroides sistémicos.
3. Uso de antibióticos sistémicos en los 10 últimos días anteriores a la selección.
4. Uso de FAINE sistémicos repetidamente en los 10 últimos días anteriores a la selección.
5. Uso de probióticos iniciado en los 10 últimos días anteriores a la selección. Se permite una pauta estable desde al menos 10 días antes de la selección, pero el paciente debe estar dispuesto a continuar hasta el final del estudio.
6. Uso de inmunosupresores o productos biológicos en las 6 últimas semanas anteriores a la selección.
7. Cultivo fecal positivo para patógenos entéricos (p. ej.: Shigella, Salmonella, Yersinia, Campylobacter) o toxinas (C.difficile).
8. Deterioro significativo de la función hepática, renal, pulmonar o cardiovascular, evaluadas por el investigador.
9. Antecedentes de resección del colon.
10. Diverticulitis, diverticulosis sintomática.
11. Enfermedad de úlcera péptica activa.
12. Proctitis (grado de inflamación < 15 cm desde el ano).
13. Trastornos hemorrágicos
14. Terapia rectal con enemas terapéuticos o supositorios, con la excepción de los usados para la endoscopia, en los 10 días anteriores a la selección.
15. Infecciones o neoplasias malignas activas o crónicas.
16. Hipersensibilidad conocida al principio activo y a los excipientes del fármaco del estudio.
17. Participación simultánea en otro ensayo clínico, o participación en cualquier ensayo clínico que incluya fármacos en investigación en los 3 meses anteriores a la inclusión en el presente estudio.
18. Cualquier enfermedad física o psicológica en un paciente que pueda llevar al investigador a sospechar de un cumplimiento deficiente.
19. Tratamiento con L-carnitina o ésteres derivados en los 3 meses anteriores a la selección.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint will be the clinical/endoscopic remission defined as a Disease Activity Index at the end of treatment ? 2 with rectal bleeding sub-score = 0 and no other individual sub-score >1.

El criterio de valoración principal será la remisión clínica/endoscópica definida como un Índice de Actividad de la Enfermedad al final del tratamiento ? 2 con una puntuación de hemorragia rectal = 0 y ninguna otra puntuación individual > 1.

E.5.1.1

Timepoint(s) of evaluation of this end point

Disease Activity Index at the end of treatment ? 2 with rectal bleeding sub-score = 0 and no other individual sub-score > 1.

Índice de Actividad de la Enfermedad al final del tratamiento ? 2 con una puntuación de hemorragia rectal = 0 y ninguna otra puntuación individual > 1.

E.5.2

Secondary end point(s)

Secondary endpoints will be:
? Rectal bleeding evaluation by means of DAI sub-score (from 0 to 3).
? Stool frequency evaluation by means of DAI sub-score (from 0 to 3).
A clinical response for each of these parameters is defined as a sub-score improvement of at least 1 point over baseline.
The histological response to the treatments, defined as an improvement of the Histological Index (HI ? see Appendix III) of at least 1 point at the end of the study (a final HI score of ?1 will be defined as a histological remission) will also be evaluated as additional exploratory end-point.
The serum C-reactive protein and Fibrinogen will be monitored to investigate possible correlation between clinical/endoscopic outcome and serum level of these inflammatory markers.
A validated specific questionnaire, the SIBDQ by McMaster University, will be administered to evaluate changes in patients? Quality of Life.
The safety and tolerability of the treatments will be investigated through AEs recording, vital signs, ECG and laboratory evaluation.

Los criterios de valoración secundarios serán:
? Evaluación de la hemorragia rectal mediante la puntuación del IAE (de 0 a 3).
? Evaluación de la frecuencia de deposiciones mediante la puntuación del IAE (de 0 a 3).
Una respuesta clínica para cada uno de estos parámetros se define como una mejoría en la puntuación de al menos 1 punto con respecto al valor inicial.
La respuesta histológica a los tratamientos, definida como una mejoría del índice Histológico (IH - ver Apéndice III) de al menos 1 punto al final del estudio (una puntuación final en el IH de ?1 se definirá como una remisión histológica) también se evaluará como un criterio de valoración exploratorio adicional.

La proteína C reactiva y el fibrinógeno en suero se controlarán para investigar una posible correlación entre el resultado clínico/endoscópico y el nivel de suero de estos marcadores inflamatorios.

Se administrará un cuestionario específico validado, el SIBDQ de la McMaster University, para evaluar los cambios en la calidad de vida de los pacientes.
La seguridad y tolerabilidad de los tratamientos serán investigadas mediante los registros de AA, las constantes vitales, los ECG y la evaluación del laboratorio.

E.5.2.1

Timepoint(s) of evaluation of this end point

A clinical response for each of these parameters is defined as a sub-score improvement of at least 1 point over baseline.
The histological response to the treatments, defined as an improvement of the Histological Index (HI ? see Appendix III) of at least 1 point at the end of the study (a final HI score of ?1 will be defined as a histological remission) will also be evaluated as additional exploratory end-point.
The serum C-reactive protein and Fibrinogen will be monitored to investigate possible correlation between clinical/endoscopic outcome and serum level of these inflammatory markers.
A validated specific questionnaire, the SIBDQ by McMaster University, will be administered to evaluate changes in patients?

La respuesta histológica a los tratamientos, definida como una mejoría del índice Histológico (IH - ver Apéndice III) de al menos 1 punto al final del estudio (una puntuación final en el IH de ?1 se definirá como una remisión histológica) también se evaluará como un criterio de valoración exploratorio adicional.
La proteína C reactiva y el fibrinógeno en suero se controlarán para investigar una posible correlación entre el resultado clínico/endoscópico y el nivel de suero de estos marcadores inflamatorios.
Se administrará un cuestionario específico validado, el SIBDQ de la McMaster University, para evaluar los cambios en la calidad de vida de los pacientes.

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

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

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

Austria

France

Germany

Hungary

Latvia

Lithuania

Poland

Spain

E.8.7

Trial has a data monitoring committee

Yes

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

End of the trial will be when the last patient enrolled complete the study proceds for last visit.
A patient (even last ptient enrolled) can finalize the study participation when:
a.development of any adverse event by reason of which continuation in the trial is considered inappropriate;
b.patient?s request to discontinue for any reason;
c.needing to start a not allowed concomitant therapy;
d.pregnancy.

El final del estudio se considerará cuando el último paciente incluido complete los procedimientos para la última visita.
Un paciente (hasta el último paciente incluido) puede finalizar su participación en el estudio por:
a.desarrollo de cualquier acontecimiento adverso por el cual la continuación en el ensayo se considere inadecuada;
b.petición del sujeto de retirarse por cualquier motivo;
c.necesidad de empezar un tratamiento concomitante no permitido;
d.embarazo.

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

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:

444

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

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

444

F.4.2.2

In the whole clinical trial

444

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

2012-02-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-08-13

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