Clinical Trials Register

Summary
EudraCT Number:	2015-002672-25
Sponsor's Protocol Code Number:	STR001-201
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:	2016-09-09
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

2015-002672-25

A.3

Full title of the trial

A Phase II multicenter, placebo-controlled, proof-of-concept study evaluating the safety, and efficacy of intratympanic STR001 thermogel to preserve residual hearing in adults undergoing cochlear implant surgery

Estudio multicéntrico en fase II, controlado con placebo, de viabilidad que evalúa la seguridad y la eficacia del termogel STR001 intratimpánico para conservar la audición residual en adultos sometidos a cirugía de implante coclear.

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

STR001-201

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	Strekin AG
B.1.3.4	Country	Switzerland
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	Strekin AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Recerca Clínica SL
B.5.2	Functional name of contact point	Yolanda Soler
B.5.3	Address:
B.5.3.1	Street Address	Calle Llull 393,entlo.3
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08019
B.5.3.4	Country	Spain
B.5.4	Telephone number	34629760411
B.5.5	Fax number	34934851401
B.5.6	E-mail	soler.y@recercaclinica.es

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	Pioglitazone hydrochloride product
D.3.2	Product code	STR001
D.3.4	Pharmaceutical form	Cutaneous suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intratympanic use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pioglitazone hydrochloride
D.3.9.1	CAS number	111025-46-8
D.3.9.2	Current sponsor code	STR001
D.3.9.3	Other descriptive name	PIOGLITAZONE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03834MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.2
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	Cutaneous suspension
D.8.4	Route of administration of the placebo	Intratympanic use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with a diagnosis of severe to profound hearing loss eligible for cochlear implant surgery . This study To evaluate the safety and tolerability of STR001 thermogel in patients receiving cochlear implant

Pacientes con un diagnóstico de pérdida auditiva grave a profunda que se someterán a una cirugía de implante coclear. El estudio evalúa la seguridad y la eficacia del termogel STR001 intratimpánico para conservar la audición residual en adultos sometidos a cirugía de implante coclear.

E.1.1.1

Medical condition in easily understood language

Patients with a diagnosis of severe to profound hearing loss eligible for cochlear implant surgery

Pacientes con un diagnóstico de pérdida auditiva grave a profunda que se someterán a una cirugía de implante coclear.

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the safety and tolerability of STR001 thermogel in patients receiving cochlear implants
To assess the efficacy of STR001 thermogel in preserving hearing 6 weeks after cochlear implant surgery as determined by average Pure Tone Audiometry (aPTA) values

Evaluar la seguridad y la tolerabilidad del termogel STR001 en pacientes que reciben implantes cocleares.
Evaluar la eficacia del termogel STR001 en la conservación de la audición 6 semanas después de una cirugía de implante coclear, de acuerdo con los valores medios de una audiometría tonal liminar (aPTA).

E.2.2

Secondary objectives of the trial

To evaluate secondary efficacy parameters of hearing on average Bone Conduction Threshold Audiometry (aBCTA) and individual frequencies by BCTA and PTA.
To evaluate the systemic exposure of STR001 after STR001 thermogel administration

Evaluar los parámetros de eficacia secundarios de la audición mediante los valores medios de la audiometría del umbral de conducción ósea (aBCTA) y las frecuencias individuales por BCTA y PTA.
Evaluar la exposición sistémica a STR001 después de la administración de termogel STR001.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Males or females aged between > 18 years and ≤ 80 years
2. Patients with a diagnosis of severe to profound hearing loss with < 80 dB by average Pure Tone Audiometry measured at the frequencies of 125, 250, 500 and 750Hz, eligible for cochlear implant surgery (average up to 82.5 will be rounded down to 80 i.e. will be considered eligible).
3. Patients must be willing and capable to perform all study procedures
4. Patients have understood the patient information documents and have provided informed consent
5. Females must have a negative serum pregnancy test or must be post- menopausal

1. Hombres o mujeres de 18 a 80 años.
2. Pacientes con un diagnóstico de pérdida auditiva grave a profunda, con ≤ 80 dB por audiometría tonal liminar en las frecuencias de 125, 250, 500 y 750 Hz, elegibles para una cirugía de implante coclear (una media de hasta 82,5 se redondeará a 80, es decir, se considerará elegible).
3. Pacientes dispuestos y capacitados para realizar todos los procedimientos del estudio.
4. Pacientes que han comprendido los documentos de información para el paciente y han dado su consentimiento informado.
5. Mujeres con un resultado negativo en la prueba de embarazo en suero o posmenopáusicas.

E.4

Principal exclusion criteria

1. Malformation or cochlear ossification
2. Developmental disabilities or psychiatric diseases such as severe depression
3. History of Meniere’s disease
4. Acute or chronic middle ear inflammatory disease
5. Use of thiazolidinedione (e.g. pioglitazone, rosiglitazone) in the last 6 months prior to baseline
6. Chronic (i.e. at least 3 continuous months) oral steroids in the last 6 months prior to baseline
7. Daily nasal/pulmonary steroid in the last month prior to baseline
8. Fibrates (e.g. gemfibrozil, fenofibrate) in the last 6 months prior to Baseline
9. Patients with known hypersensitivity to pioglitazone or any formulation component
10. Initiation of treatment with lipophilic statins (e.g. atorvastatin, pitavastatin, lovastatin, fluvastatin or simvastatin) in the month prior to inclusion in the study. Patients on stable doses of lipophilic statins should continue therapy during the study.
11. Any drug-based therapy for inner ear hearing loss in the last month prior to baseline
12. Women who are breast feeding, pregnant, or plan to get pregnant during the trial
13. Women of childbearing potential unwilling/unable to practice contraception
14. Participation in other clinical trials in the last month prior to baseline
15. Patients who are institutionalized upon authorities or legal request
16. Patients who are vulnerable (e.g. employees or relatives of sponsor, investigator or investigational site staff or patients in emergency situations)
17. Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria)

1. Malformación u osificación coclear.
2. Discapacidades del desarrollo o enfermedades psiquiátricas, como depresión grave.
3. Antecedentes de enfermedad de Ménière.
4. Enfermedad inflamatoria aguda o crónica del oído medio.
5. Uso de tiazolidinodionas (por ejemplo, pioglitazona, rosiglitazona) en los 6 meses anteriores al momento basal.
6. Uso crónico (es decir, al menos durante 3 meses seguidos) de esteroides orales en los 6 meses anteriores al momento basal.
7. Uso diario de esteroides nasales/pulmonares en el mes anterior al momento basal.
8. Uso de fibratos (por ejemplo, gemfibrozilo, fenofibrato) en los 6 meses anteriores al momento basal.
9. Pacientes con hipersensibilidad conocida a la pioglitazona o a cualquier componente de la formulación.
10. Inicio de un tratamiento con estatinas lipofílicas (por ejemplo, atorvastatina, pitavastatina, lovastatina, fluvastatina o simvastatina) en el mes anterior a la inclusión en el estudio. Los pacientes que toman dosis estables de estatinas lipofílicas deben continuar el tratamiento durante el estudio.
11. Cualquier tratamiento farmacológico para la pérdida auditiva del oído interno que esté en curso o se haya realizado en el mes anterior al momento basal.
12. Mujeres lactantes o embarazadas o que prevean quedarse embarazadas durante el estudio.
13. Mujeres fértiles que no deseen o no puedan usar métodos anticonceptivos.
14. Participación en otros estudios clínicos en el mes anterior al momento basal.
15. Pacientes institucionalizados por las autoridades o por requerimiento legal.
16. Pacientes vulnerables (por ejemplo, empleados o familiares del promotor, del investigador o del personal del centro de investigación o pacientes en situaciones de urgencia).
17. Pacientes en los que está contraindicada la administración oral de pioglitazona (es decir, pacientes con insuficiencia cardíaca o con antecedentes de insuficiencia cardíaca [grados I-IV de la NYHA], insuficiencia hepática, cetoacidosis diabética, cáncer de vejiga actual o antecedentes de cáncer de vejiga, o hematuria macroscópica no investigada).

E.5 End points

E.5.1

Primary end point(s)

Efficacy: Average Pure Tone Audiometry Treshold (aPTA) at 125, 250, 500 and 750 Hz of implanted ear at Week 6.
Safety: The incidence and severity of adverse events, serious adverse events, deaths, as well as drug and study discontinuations; The incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results; ECGs; Physical examination; Vital signs

Eficacia: Audiometría tonal liminar media (aPTA) a 125, 250, 500 y 750 Hz del oído implantado en la semana 6.
Seguridad:Acontecimientos adversos (por gravedad), acontecimientos adversos graves, muertes, abandonos del tratamiento farmacológico y abandonos del estudio.
Análisis de laboratorio (bioquímica, hematología, análisis de orina).
Electrocardiograma. Exploración física. Constantes vitales.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 weeks after CI surgery

6 semana después el implante cochlear

E.5.2

Secondary end point(s)

Efficacy (key): BCTA of the implanted ear as the average of the following frequencies: 250, 500 and 750 Hz at Week 6.
Efficacy (other):
Pure Tone Audiometry will also be assessed at each individual frequency at 125, 250, 500 and 750 Hz at Week 6.
BCTA will also be assessed at each individual frequency at 250, 500 and 750 Hz at Week 6.
BCTA will also be assessed at each frequency: 250, 500 and 750 Hz at Week 6.
Pharmacokinetics: Pioglitazone and its main metobolites (M-III and M-IV) Plasma concentrations.

Se realizará una BCTA media del oído implantado y se evaluará como la media de los valores en las frecuencias de 250, 500 y 750 Hz en la semana 6.
También se evaluará una audiometría tonal liminar en las frecuencias de 125, 250, 500 y 750 Hz en la semana 6.
Asimismo, la BCTA se evaluará en las frecuencias de 250, 500 y 750 Hz en la semana 6.
farmacocinética: concentración en plasma de pioglitazone y sus metabolitos principales (M-III and M-IV).

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficay: 6 weeks after CI surgery
Pharmacokinetics: At baseline, prior to surgery and after the surgery (4 samples/Patient)

Eficacias: 6 semana después el implante cochlear
farmacocinética: Muestras recogidas en el momento basal, antes de la cirugía y después de la cirugía (4 muestras/paciente).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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)

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

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

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

último visita al 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

E.8.9.2

In all countries concerned by the trial years

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

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:

110

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

110

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

Information not present in EudraCT

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

110

F.4.2.2

In the whole clinical trial

110

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)

Patients will receive intratympanic administration prior to, and at the time of the surgery and hearing preservation will be assessed at 6 weeks. Since the hearing loss occurs shortly after the surgery, the benefit should be demonstrated after 6 weeks and no further treatment with STR001 is anticipated. After 6 weeks, the cochlear implant will be activated and the surgeon will continue to ensure medical care of the patients after cochlear implant activation and rehabilitation.

Los pacientes recibirán el termogel antes y en el momento de la cirugía y la preservación de la audición será evaluado a las 6 sem. Dado que la pérdida de audición se produce poco después de la cirugía, el beneficio debe ser demostrada al cabo de 6 sem. y se prevé ningún tratamiento adicional con STR001. Después de 6 sem, el implante coclear se activará y el cirujano seguirá garantizando la atención médica a los pacientes después de la activación del implante coclear y la rehabilitación.

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

2016-11-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-11-15

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