Clinical trial • Not applicable • Other
Oxycodone hydrochloride trihydrate for Labour pain
Not applicable trial of Oxycodone hydrochloride trihydrate for Labour pain. open-label. 12 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Labour pain
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 15-07-2024
- First CTIS Authorization Date
- 09-08-2024
Trial design
open-label Not applicable trial across 1 site in Finland.
- Open Label
- Yes
- Target Sample Size
- 12
- Trial Duration For Participant
- 2
Eligibility
Recruits 12 Vulnerable population selected: true. Study population are parturient (pregnant women in labour). Written informed consent required from participant (age ≥ 18). Subject information and informed consent form document listed (tiedote_suostumusoksisynnytys...)..
- Vulnerable Population
- Vulnerable population selected: true. Study population are parturient (pregnant women in labour). Written informed consent required from participant (age ≥ 18). Subject information and informed consent form document listed (tiedote_suostumusoksisynnytys...).
Inclusion criteria
- {"criterion_text":"-Oxycodone given for labour pain\n-age≥ 18 years\n-informed consent given"}
Exclusion criteria
- {"criterion_text":"-Oxycodone not used for labour pain\n-age < 18 years\n-no informed consent"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Oxycodone concentration in mater and umbilical cord at time of birth","definition_or_measurement_approach":"Measure maternal and umbilical (cord) concentrations of oxycodone soon after birth."}
Secondary endpoints
- {"endpoint_text":"-Population pharmacocinetic model of oxycodone in parturient","definition_or_measurement_approach":"Population pharmacokinetic modelling of oxycodone in parturient; assessment includes PK modelling and effects on the newborn and efficacy (as stated in secondary objectives)."}
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 12
- Consent Approach
- Written informed consent required from participant (participants must be age ≥ 18). Subject information and informed consent form available (document listed). Consent provided by the participant themselves; no assent procedures described. Materials/translations include Finnish.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 12
Finland
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 09-08-2024
- Processing Time Days
- 8
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Pohjois-Savon hyvinvointialue
- Department Name
- Anaesthesiology and Intensive Care
- Principal Investigator Name
- Merja Kokki
- Principal Investigator Email
- merja.kokki@pshyvinvointialue.fi
- Contact Person Name
- Merja Kokki
- Contact Person Email
- merja.kokki@pshyvinvointialue.fi
- Number Of Participants
- 12
Sponsor
Primary sponsor
- Full Name
- Pohjois-Savon hyvinvointialue
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- Oxanest® 10 mg/ml -injektioneste, liuos
- Active Substance
- Oxycodone hydrochloride trihydrate
- Modality
- Small molecule
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised (marketing authorisation number 6646, FI)
- Maximum Dose
- Max daily dose 20 mg; max total dose 40 mg
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