Clinical Trials Register

Summary
EudraCT Number:	2012-003188-23
Sponsor's Protocol Code Number:	01-07-2012
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-09-13
Trial 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

Finland - Fimea

A.2

EudraCT number

2012-003188-23

A.3

Full title of the trial

Opioidien aiheuttama mahasuolikanavan toiminnanhäiriö keisarileikkauspotilailla

A.3.1

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

Opioidien aiheuttama mahasuolikanavan toiminnanhäiriö keisarileikkauspotilailla

A.3.2

Name or abbreviated title of the trial where available

Oksisektio

A.4.1

Sponsor's protocol code number

01-07-2012

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	Merja Kokki
B.1.3.4	Country	Finland
B.3.1 and B.3.2	Status of the sponsor	Non-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	Kuopion yliopistollinen sairaala
B.5.2	Functional name of contact point	Merja Kokki
B.5.3	Address:
B.5.3.1	Street Address	PL1777
B.5.3.2	Town/ city	Kuopio
B.5.3.3	Post code	70800
B.5.3.4	Country	Finland
B.5.4	Telephone number	35817173311

D. IMP Identification
D.IMP: 1
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	Oxycontin 10 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Mundipharma Oy
D.2.1.2	Country which granted the Marketing Authorisation	Finland
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	Oxycontin
D.3.2	Product code	N02AA05
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	Oksikodoni hydrokloridi
D.3.9.1	CAS number	124-90-3
D.3.9.3	Other descriptive name	OXYCODONE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03583MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
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	Targiniq 10/5 mg depottabletti
D.2.1.1.2	Name of the Marketing Authorisation holder	Mundipharma Oy
D.2.1.2	Country which granted the Marketing Authorisation	Finland
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	Targiniq 10/5 mg
D.3.2	Product code	N02AA55
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	Oksikodoni hydrokloridi
D.3.9.1	CAS number	124-90-3
D.3.9.3	Other descriptive name	OXYCODONE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03583MIG
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Naloksoni hydrokloridi
D.3.9.3	Other descriptive name	NALOXONE HYDROCHLORIDE HYDRATE
D.3.9.4	EV Substance Code	SUB25430
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Keisarileikkauksen jälkeinen kipu

E.1.1.1

Medical condition in easily understood language

Keisarileikkauksen jälkeinen kipu

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10051798
E.1.2	Term	Postoperative constipation
E.1.2	System Organ Class	100000004863

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10071128
E.1.2	Term	Opioid induced constipation
E.1.2	System Organ Class	100000004856

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10054711
E.1.2	Term	Postoperative pain
E.1.2	System Organ Class	100000004863

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10048862
E.1.2	Term	Cesarean section
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Ummetuksen ilmeneminen sairaalassa olo aikana leikkauksen jälkeen.

E.2.2

Secondary objectives of the trial

Turvallisuusmuuttujana arvioidaan ilmeneviä haittavaikutuksia ja oksikodonipitoisuuksia äidinmaidossa ja äidin verenkierrossa, mahdollista vaikutusta vastasyntyneeseen, tehomuuttujana sairaalahoidon aikana tarvittavaa lisäkipulääkitystä ja kivun voimakkuutta viikon kuluttua leikkauksesta, ja hoitomyöntyvyysmuuttujana potilaiden ilmoittamaa tyytyväisyyttä toteutettuun kivunhoitoon.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Suunniteltu elektiivinen sektio puudutuksessa
• Normaalisti edennyt täysiaikainen raskaus
• Ikä ≥18 vuotta
• BMI 20 - 35 kg/m2
• Tutkittava ymmärtää suunnitellun tutkimuksen ja siinä tehtävät toimenpiteet
• Tutkittava on antanut kirjallisen suostumuksen tutkimukseen osallistumisesta

E.4

Principal exclusion criteria

• Ikä < 18
• BMI < 20 ja >35 kg/m2
• Potilas on tai on ollut mukana muussa lääketutkimuksessa edeltävän kuukauden aikana
• Yliherkkyys oksikodonille, naloksonille tai valmisteen sisältämille aineosille
• Lääkkeiden ja päihteiden väärinkäyttö
• MAO-estäjien käyttö, CYP3A4 inhibiittorien, kuten ketokonatsolin käyttö, CYP2D6 inhibiittorien, kuten paroksetiinin käyttö edeltävän kuukauden aikana
• Tiedossa oleva ruuansulatuskanavan imeytymishäiriö tai muu tila jonka arvioidaan voivan vaikuttaa lääkkeen imeytymiseen
• Aiempi ruuansulatuskanavaan kohdistunut leikkaus, jonka arvioidaan voivan vaikuttaa lääkkeiden imeytymiseen
• Munuaisten vajaatoiminta
• Maksan vajaatoiminta
• Uniapnea tai muu hengityskeskuksen toimintahäiriö
• Keuhkoahtaumatauti, tai muu vaikea keuhkosairaus
• Vajaakykyisyys
• Tutkittava ei ole antanut kirjallista suostumusta
• Muu syy, jonka takia tutkija arvioi, ettei potilas sovi tutkimukseen

E.5 End points

E.5.1

Primary end point(s)

Leikkauksen jälkeen ilmenevä ummetus

E.5.1.1

Timepoint(s) of evaluation of this end point

Potilaalta kysytään ummetus ennen leikkausta raskauden aikana, kotiin lähtiessä, 7 ja 21 vrk kotiin lähdön jälkeen

E.5.2

Secondary end point(s)

ilmenevät haittavaikutukset
oksikodonipitoisuudet äidinmaidossa ja äidin veressa
sairaalahoidon aikana tarvittava lisäkipulääkitys
kivun voimakkuus viikon kuluttua leikkauksesta
potilaan tyytyväisyyttä toteutettuun kivunhoitoon

E.5.2.1

Timepoint(s) of evaluation of this end point

Haittavaikutukset päivittäin
Oksikodonipitoisuudet 2 krt/vr sairaalassaoloajan eli n 3 vrk lisäkipulääkityksen tarve ja kivun voimakkuus sairaalassaoloaikana päivittäin ja viikon kuluttua leikkauksesta
tyytyväisyys toteutettuun kivunhoitoon kotiin lähtiessä

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

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)

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

Yes

E.8.1.4

Double blind

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

E.8.2.3

Other

E.8.2.3.1

Comparator description

Oksikodoni naloksoni Targiniq 10/5 mg

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

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

Tutkimus lopuu 21 vrk leikkauksesta tehtyyn puhelinkyselyyn.
Potilaiden kivunhoito kotiutuessa määräytyy hoitavan lääkärin ohjeiden ja sairaalan normaalikäytännön mukaan

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

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:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

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.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)

Hoitava lääkäri määrää kipulääkityksen kotiin

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

2012-09-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-08-07

P. End of Trial
P.	End of Trial Status	Ongoing

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