Clinical Trials Register

Summary
EudraCT Number:	2008-003190-41
Sponsor's Protocol Code Number:	NETU-08-03
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-07-30
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

Germany - BfArM

A.2

EudraCT number

2008-003190-41

A.3

Full title of the trial

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Prospective Study to Assess the Efficacy, Safety and Tolerability of Three Oral Doses of Netupitant Given Once a Day (50, 100 and 200 mg) vs Placebo in Patients with Overactive Bladder.

A.4.1

Sponsor's protocol code number

NETU-08-03

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	Helsinn Healthcare SA
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
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	Netupitant
D.3.2	Product code	14-NETU
D.3.4	Pharmaceutical form	Capsule, soft
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	Netupitant
D.3.9.1	CAS number	290297-26-6
D.3.9.2	Current sponsor code	Netupitant
D.3.9.3	Other descriptive name	NETU-14,Ro-0673189
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	50 to mg
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	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	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	Netupitant
D.3.2	Product code	14-NETU
D.3.4	Pharmaceutical form	Capsule, soft
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	Netupitant
D.3.9.1	CAS number	290297-26-6
D.3.9.2	Current sponsor code	Netupitant
D.3.9.3	Other descriptive name	NETU-14,RO0673189
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	150 to mg
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	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	Capsule, soft
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, soft
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

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	10059617
E.1.2	Term	Overactive bladder

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 assess efficacy, safety and tolerability of three different, repeated oral doses of netupitant in patients with symptoms of OAB

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and female patients ≥ 18 years old
2. Symptoms of overactive bladder for at least 6 months before entering the run-in, single-blind treatment period
3. Able to read, understand and follow the study procedures and complete OAB diary
4. Willing and able to sign informed consent
5. If female, they must be either post-menopausal for at least 12 months or surgically sterilized. In case of fecund women, they must use a reliable method of contraception such as a combination of spermicidal / barrier method (condom, sponge, foam, jelly, or diaphragm) or intrauterine devices which do not involve the use of steroid hormones.
6. Baseline 3 day diary (to be recorded during the last three days before visit # 2), reporting ≥ 3 urgency episodes, with or without ≥ 3 incontinence episodes, and with 10-20 micturitions/24 hours

E.4

Principal exclusion criteria

1. Breast feeding
2. Grade III/IV pelvic organ prolapse with or without cystocele
3. History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within 6 months of screening
4. Stress incontinence or mixed incontinence where the stress incontinence prevails
5. Urinary incontinence due to causes other than overactive bladder
6. Nocturnal enuresis only
7. Residual urinary volume > 200 ml measured by ultrasound
8. Current repeated Urinary Tract Infections (UTIs): > 4 episodes/year
9. Bladder cancer
10 History of unstable angina and/or congestive heart failure
11. History or predisposition to cardiac conduction abnormalities
12. History of risk factors for Torsade de Point (heart failure, hypokalemia, family history of Long QT Syndrome)
13. History of radiation cystitis or history of pelvic irradiation
14. Electro-stimulation, biofeedback, bladder training therapy (behavioral therapy) within 3 months of the screening visit and/or during the study
15. Investigational treatments within 30 days of start of run-in
16. Any neurological disease that may affect bladder function or muscle strength
17. Chronic alcohol or drug abuse
18. Diabetes insipidus
19. Diabetes mellitus type I or II with peripheral neuropathy and/or polyuria
20. Previous or concomitant local administration of botulinum toxin in the lower urinary tract
21.Chronic inflammatory bowel diseases such as Chron’s Disease and ulcerative colitis
22. Previous or concomitant treatment with NK1 receptor antagonists
23. Known contra-indications to NK1 receptor antagonists
24. Concomitant treatment with anti-muscarinic drugs. Patients on treatment with anti-muscarinic drugs and willing to participate will need to stop their administration from visit 1 throughout the study duration, including visit # 7.
25. Neoplastic disorder which is either active or has been in remission for less than one year
26. Chronic use of any CYP 3A4 substrates or inhibitors (e.g. terfenadine, cisapride, astemizole, clarythromycine, ketoconazole or itraconazole) (See appendix # 2, page 60 protocol)
27. Chronic use of any CYP 3A4 inducers (e.g. barbiturates, rifampicin, rifabutin, phenytoin, or carbamazepine) (See appendix # 2, page 60 protocol)
28. History or current diagnosis of HIV, or of any type of viral hepatitis
29. Concomitant use of α-blockers, α-adrenergic agonists, unless given at stable doses for at least 3 months of the screening visit and remaining stable throughout the study duration
30.Pregnancy
31. Polyuria (diuresis > 3 L/24 hours)
32. History of interstitial cystitis or bladder related pain
33. Any local pathology that might cause bladder symptoms
34. Severe, uncontrolled arterial hypertension or myocardial infarction < 3 months, congestive heart failure, active coronary artery disease
35. Use of concomitant medications that prolong the QT/QTc interval
36. History of any illness that, in the opinion of the investigator, may confound the results of the study or pose unwarranted risk in administering the study drug to the patient
37. Concomitant diseases likely to interfere with the study drug (capable of altering absorption, metabolism or excretion
38. Marked baseline prolongation of QT/QTc interval [QTc >460 msec]; QRS > 110 msec; PR > 240 msec; HR < 55 bpm; atrial fibrillation; complete left bundle branch block. For this purpose, the ECG performed at screening visit will be assessed.
39. Abnormal laboratory values including:
a. AST (Aspartate Aminotransferase) > 2.5 x Upper Limit of Normal
b. ALT (Alanine Aminotransferase) > 2.5 Upper Limit of Normal
c. Bilirubin > 1.5 x Upper Limit of Normal
d. Creatinine > 1.5 x Upper Limit of Normal

E.5 End points

E.5.1

Primary end point(s)

Percentage change from the baseline in the average number of daily micturitions (primary)

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability

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

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.8.3

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

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	No
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)	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	35
F.4.2	For a multinational trial
F.4.2.1	In the EEA	155
F.4.2.2	In the whole clinical trial	240

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

2008-10-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-10-30

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-05-06

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