Overview
Sponsor-declared trial summary
labour
Transition Trial: Maternal and umbilical concentrations of oxycodone soon after birth.
Key facts
- Sponsor
- Pohjois-Savon hyvinvointialue
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 12 Aug 2024 → ongoing
- Decision date (initial)
- 2024-08-09
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Suomen kulttuurirahasto
External identifiers
- EU CT number
- 2024-516495-15-00
- EudraCT number
- 2012-003189-42
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety
Transition Trial: Maternal and umbilical concentrations of oxycodone soon after birth.
Secondary objectives 1
- oxycodone population pharmacokinetic modelling, efficacy and effect to the newborn
Conditions and MedDRA coding
labour
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10059204 | Labour pain | 100000004868 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Synnytyskivun lievitykseen käytetyn oksikodonin teho ja turvallisuus, vaikutukset vastasyntyneeseen Observational pharmacokinetic study
|
Not Applicable | None | Oksicodone: Given oxycodone |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Oxycodone given for labour pain, age≥ 18 years, informed consent given
Exclusion criteria 1
- Oxycodone not used for labour pain, age < 18 years, no informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Oxycodone concentration in mater and umbilical cord at time of birth
Secondary endpoints 1
- Population pharmacocinetic model of oxycodone in parturient
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Oxanest® 10 mg/ml -injektioneste, liuos
PRD11445655 · Product
- Active substance
- Oxycodone Hydrochloride Trihydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA05 — OXYCODONE
- Marketing authorisation
- 6646
- MA holder
- TAKEDA OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pohjois-Savon hyvinvointialue
- Sponsor organisation
- Pohjois-Savon hyvinvointialue
- Address
- Puijonlaaksontie 2, P. O. Box 1711 P. O. Box 1711
- City
- Kuopio
- Postcode
- 70211
- Country
- Finland
Scientific contact point
- Organisation
- Pohjois-Savon hyvinvointialue
- Contact name
- Merja Kokki
Public contact point
- Organisation
- Pohjois-Savon hyvinvointialue
- Contact name
- Merja Kokki
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2024-08-12 | 2024-08-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | lisaselvityksen tarkennus oksisynnytys fimea31_8_2021 | 2 |
| Protocol (for publication) | TUTKIMUSSUUNNITELMA Oksisynnytys 23_8_2021 | 5 |
| Recruitment arrangements (for publication) | selvitus tutkittavien valitsemisesta oksisynnytystrans | 1 |
| Subject information and informed consent form (for publication) | tiedote_suostumusoksisynnytys 20_7_2021 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | oxanest SmPC-2 | 1 |
| Synopsis of the protocol (for publication) | tiivistelma Oksisynnytys22_10_12transition | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-15 | Finland | Acceptable with conditions 2024-08-08
|
2024-08-09 |