Influence of pregabalin and lacosamide on the respiratory depression caused by oxycodone

Combined effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on breathing: an exploratory study in healthy volunteers the POLO study - POLO study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001603-40-NL

Enrollment

Registered

2022-06-21

Start date

2022-07-18

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Interventions

Trade Name: Oxycodone Product Name: Oxycodone Product Code: RVG 106669 Pharmaceutical Form: Tablet Trade Name: Vimpat Product Name: Lacosamide Product Code: N03AX18 Pharmaceutical Form: Film-coated t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - aged 18-45 years, - body mass index =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Presence or history of any medical or psychiatric disease (incl. a history of substance abuse, anxiety, or the presence of a painful syndrome such as fibromyalgia); - Use of any medication in the three months prior to the study (incl. paracetamol or other pain killers); - Use of more than 21 alcohol units per week; - A positive urinary drug test or a breath alcohol test at screening or on the morning of the experiment; - Pregnancy, lactating or a positive pregnancy test on the morning of the experiment; - Participation in another drug trial in the 60 days prior to dosing.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is to quantify the effect of pregabaline and lacosamide on oxycodone-induced respiratory depression.;Secondary Objective: (1) Level of sedation; (2) Relief of nociception; (3) Occurrence of nausea/vomiting; (4) pupil diameter; (5) baseline ventilation. ;Primary end point(s): The primary endpoint of the study the extrapolated end-tidal PCO2 at 55 mmHg (7.3 kPa) or VE55, 4-h following the intake of oxycodone. ;Timepoint(s) of evaluation of this end point: 4-h following the intake of oxycodone.	—

Measure

Time frame

Main Objective: The objective of the study is to quantify the effect of pregabaline and lacosamide on oxycodone-induced respiratory depression.;Secondary Objective: (1) Level of sedation; (2) Relief of nociception; (3) Occurrence of nausea/vomiting; (4) pupil diameter; (5) baseline ventilation. ;Primary end point(s): The primary endpoint of the study the extrapolated end-tidal PCO2 at 55 mmHg (7.3 kPa) or VE55, 4-h following the intake of oxycodone. ;Timepoint(s) of evaluation of this end point: 4-h following the intake of oxycodone.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 0-8hrs after oxycodone intake;Secondary end point(s): (1) Level of sedation; (2) Relief of nociception; (3) Occurrence of nausea/vomiting; (4) Pupil diameter; (5) Baseline ventilation	—

Countries

Netherlands

Contacts

Public ContactMonique van Velzen

Leiden University Medical Center

M.van_velzen@lumc.nl310715262301

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026