Clinical Trials Register

Summary
EudraCT Number:	2010-024181-22
Sponsor's Protocol Code Number:	A0221095
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-02
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2010-024181-22

A.3

Full title of the trial

A 12-WEEK, PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED,PARALLEL GROUP, MULTICENTER TRIAL IN OVERACTIVE BLADDER SUBJECTS TO CONFIRM THE EFFICACY OF 8 MG FESOTERODINE COMPARED TO 4 MG FESOTERODINE.

SPERIMENTAZIONE DI 12 SETTIMANE, DI FASE 4, RANDOMIZZATA, IN DOPPIO CIECO, CONTROLLATA CON PLACEBO, A GRUPPI PARALLELI E MULTICENTRICA IN PAZIENTI CON VESCICA IPERATTIVA VOLTA A CONFERMARE L'™EFFICACIA DI FESOTERODINA 8 MG RISPETTO A FESOTERODINA 4 MG

A.3.1

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

A study to confirm the effectiveness of 8mg of fesoterodine compared to 4mg fesoterodine in subjects with overactive bladder.

Uno studio volto a confermare l'efficacia di 8mg di fesoterodine verso 4mg di fesoterodine in soggetti con vescica iperattiva.

A.3.2

Name or abbreviated title of the trial where available

EIGHT

A.4.1

Sponsor's protocol code number

A0221095

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01302067

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	PFIZER 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	Pfizer Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer Inc.
B.5.2	Functional name of contact point	Clinical Trials.gov Call Center
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	001 800 7181021
B.5.5	Fax number	001 303 739 1119
B.5.6	E-mail	ClinicalTrials.govCallCentrere@pfizer.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	Yes
D.2.1.1.1	Trade name	Toviaz
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	Pharmaceutical form	Prolonged-release 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	FESOTERODINE
D.3.9.1	CAS number	286930-03-8
D.3.9.2	Current sponsor code	A0221095
D.3.9.3	Other descriptive name	fesoterodine fumarate
D.3.9.4	EV Substance Code	NA
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	4
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.IMP: 2
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	Yes
D.2.1.1.1	Trade name	Toviaz
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	Pharmaceutical form	Prolonged-release 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	FESOTERODINE
D.3.9.1	CAS number	286930-03-8
D.3.9.2	Current sponsor code	A0221095
D.3.9.3	Other descriptive name	fesoterodine fumarate
D.3.9.4	EV Substance Code	NA
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	8
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

Overactive bladder

Vescica iperattiva

E.1.1.1

Medical condition in easily understood language

Overactive bladder

Vescica iperattiva

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

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	10059617
E.1.2	Term	Overactive bladder
E.1.2	System Organ Class	10038359 - Renal and urinary 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 demonstrate the greater efficacy of 8 mg of fesoterodine compared to 4 mg fesoterodine in reducing UUI in subjects with OAB after 12 weeks of treatment.

Dimostrare la superiore efficacia di fesoterodina 8 mg rispetto a fesoterodina 4 mg nel ridurre l’incontinenza urinaria da urgenza (UUI) in pazienti con vescica iperattiva (OAB) dopo 12 settimane di trattamento.

E.2.2

Secondary objectives of the trial

To determine the efficacy of 8 mg fesoterodine and 4 mg fesoterodine on diary endpoints after 4 and 12 weeks of treatment and patient reported outcomes (PRO) after 12 weeks of treatment in subjects with OAB. To determine the efficacy of 8 mg fesoterodine and 4 mg fesoterodine compared to placebo on diary endpoints after 4 and 12 weeks of treatment and patient reported outcomes (PRO) after 12 weeks of treatment in subjects with OAB. To summarize safety and tolerability data for 12 weeks of treatment with fesoterodine 8 mg and 4 mg and placebo in subjects with OAB.

Determinare l’efficacia di fesoterodina 8 mg e fesoterodina 4 mg sugli endpoint del diario dopo 4 e 12 settimane di trattamento e sui risultati riferiti dai pazienti (PRO) dopo 12 settimane di trattamento in pazienti con OAB. Determinare l’efficacia di fesoterodina 8 mg e fesoterodina 4 mg rispetto al placebo sugli endpoint del diario dopo 4 e 12 settimane di trattamento e sui risultati riferiti dai pazienti (PRO) dopo 12 settimane di trattamento in pazienti con OAB. Riassumere i dati di sicurezza e tollerabilità nell’arco delle 12 settimane di trattamento di fesoterodina 8 mg, 4 mg e placebo nei pazienti con OAB.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

At Screening V1 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Male or female subjects aged ≥18. 3. Overactive bladder symptoms (subject-reported) for ≥6 months prior to screening/Visit 1 according to ICS guidelines. 4. Rate their bladder condition as ''Some Moderate Problems'', ''Severe Problems'', or ''Many Severe Problems'' on the Patient Perception of Bladder Condition (PPBC) questionnaire. 5. Female subjects must not be pregnant, nursing, or have a positive urine pregnancy test or be intending to become pregnant within 3 months after the completion of the trial. Female subjects of childbearing potential who are heterosexually active must use an adequate form of contraception to prevent pregnancy during the study. Reliable contraceptive methods may include intrauterine devices (IUD), contraceptive pills of combination type, hormonal implants, injectable contraceptives or latex condoms with a spermicide 6. Subjects who are willing and able to comply with scheduled visits, the self completion of study questionnaires and symptom diaries, and other trial-related activities.

Allo screening V1 1. Evidenza di un documento di consenso informato personalmente firmato e datato che indichi che il paziente (o un rappresentante legalmente accettabile) è stato informato su tutti gli aspetti pertinenti allo studio. 2. Pazienti di ambo i sessi di età pari o superiore a 18 anni. 3. Sintomi di vescica iperattiva (riportati dal paziente) per ≥ 6 mesi precedenti lo screening/Visita 1 secondo le linee guida ICS. 4. Classificazione della condizione della vescica come “Alcuni problemi moderati”, “Problemi gravi” o “Molti problemi gravi” nel questionario sulla Percezione del paziente riguardo la patologia della vescica (PPBC). 5. Le pazienti di sesso femminile non devono essere in stato di gravidanza, in allattamento o presentare un test di gravidanza urinario positivo né devono essere intenzionate ad iniziare una gravidanza nei 3 mesi seguenti la fine della sperimentazione. Le donne in età fertile ed eterosessualmente attive devono usare una forma adeguata di contraccezione per evitare una gravidanza durante il periodo dello studio. Metodi contraccettivi affidabili possono includere dispositivi intrauterini (IUD), la pillola contraccettiva orale combinata, impianti ormonali, contraccettivi iniettabili o preservativi in lattice con uno spermicida. 6. I pazienti che siano disposti e siano in grado di attenersi alle visite programmate, alla compilazione personale dei questionari di studio e dei diari dei sintomi, e ad altre attività relative allo studio.

E.4

Principal exclusion criteria

1. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. 2. Any condition that would contraindicate their use of fesoterodine including: hypersensitivity to fesoterodine fumarate or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon. 3. Conditions or prior treatment that may also affect bladder function: a. Neurologic conditions such as spinal dysraphism, stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease, which are known or suspected of influencing the subject's bladder function. b. Significant pelvic organ prolapse defined as tissue visible through introitus in lithotomy position at rest (without increase in intra abdominal pressure). c. Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator. d. Any history of major lower urinary tract/pelvic surgery with permanent or ongoing effects on bladder function. e. A known history of interstitial cystitis/bladder pain syndrome or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia, or bladder outlet obstruction due to vesical neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor, genito-urinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.

1. Pazienti che siano membri del personale del centro di sperimentazione o dipendenti di Pfizer coinvolti direttamente nella conduzione della sperimentazione. 2. Qualsiasi condizione che controindicherebbe l’uso di fesoterodina, tra cui: l’ipersensibilità alla fesoterodina fumarato o alle arachidi o alla soia o ad un qualunque eccipiente, ritenzione urinaria, ritenzione gastrica, glaucoma acuto ad angolo stretto non controllato, miastenia gravis, gravi deficit epatici (Child Pugh C), colite ulcerosa grave e megacolon tossico. 3. Condizioni o trattamento precedente che possono incidere anche sulla funzione della vescica: a. Patologie neurologiche come disrafismo spinale, ictus, sclerosi multipla, lesioni del midollo spinale, o malattia di Parkinson, che hanno nota o sospetta influenza sulla funzione della vescica del paziente. b. Significativo prolasso dell’organo pelvico definito come tessuto visibile attraverso l’orifizio vaginale in posizione litotomica a riposo (senza aumento nella pressione endoaddominale). c. Sintomi di incontinenza dovuti prevalentemente all’incontinenza urinaria da stress come determinato dallo sperimentatore. d. Qualsiasi anamnesi di chirurgia maggiore del tratto urinario inferiore o pelvica con effetti permanenti o in corso sulla funzione della vescica. e. Una anamnesi conosciuta di cistite interstiziale/sindrome dolorosa della vescica o di una componente significativa di dolore associata a sintomi OAB, ematuria non valutata, cancro urogenitale, radiazione interstiziale o esterna al bacino o ai genitali esterni, o ostruzione vescicale (BOO) dovuta a contrazione del collo vescicale, sospetto clinico di carcinoma prostatico, cisti del canale di Muller, ostruzione uretrale dovuta a stenosi/valvole/sclerosi o tumore uretrale, tubercolosi urogenitale, calcoli vescicali, o dissinergia detruso-sfinteriale.

E.5 End points

E.5.1

Primary end point(s)

Change in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at Week 12 relative to baseline (defined as those micturitions with Urinary Sensation Scale rating of 5 in the diary).

Variazione del numero medio di episodi di incontinenza da urgenza urinaria (UUI) nelle 24 ore alla settimana 12 rispetto al basale (definiti come quelle minzioni con punteggio della Urinary Sensation Scale pari a 5 nel diario).

E.5.1.1

Timepoint(s) of evaluation of this end point

12 Weeks of Treatment

12 settimane di trattamento

E.5.2

Secondary end point(s)

- Change in mean number of micturitions (frequency) per 24 hours at Weeks 4 and 12 relative to baseline; - Percent change of micturitions per 24 hours at Weeks 4 and 12 relative to baseline;

- Variazione del numero medio di minzioni (frequenza) nelle 24 ore alle Settimane 4 e 12 rispetto al basale; - Cambiamento percentuale di minzioni nelle 24 ore alle Settimane 4 e 12 rispetto ai valori basali.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. 4 & 12 weeks 2. 4 & 12 weeks 3. 4 weeks 4. 4 & 12 weeks 5. 4 & 12 weeks 6. 4 & 12 weeks 7. 12 weeks 8. 12 weeks 9. 12 weeks 10. 4 & 12 weeks

1. settimane 4 e 12 2. settimane 4 e 12 3. 4 settimane 4. settimane 4 e 12 5. settimane 4 e 12 6. settimane 4 e 12 7. 12 settimane 8. 12 settimane 9. 12 settimane 10. settimane 4 e 12

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

Yes

E.6.13.1

Other scope of the trial description

tolerability

tollerabilità

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

140

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

Argentina

Brazil

Canada

Chile

Colombia

Egypt

India

Korea, Democratic People's Republic of

Korea, Republic of

Mexico

Philippines

Russian Federation

South Africa

Taiwan

Turkey

United States

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

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

Number of subjects for this age range:

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:

1333

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

657

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

300

F.4.2

For a multinational trial

F.4.2.1

In the EEA

498

F.4.2.2

In the whole clinical trial

1990

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)

In countries where legisation requires, the sponsor agrees to provide an uninterrupted supply of study drug to study participants after they leave the trial, for a maximum period of 6 months.

Nei paesi dove la legislazione lo richiede, lo sponsor concorda nel fornire il farmaco ininterrottamente ai partecipanti allo studio dopo che hanno terminato lo studio, per un periodo massimo di 6 mesi.

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

2012-01-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-11-04

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