NCT03425084

Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to investigate the effect of known genetic variants in organic cation transporter 1 (OCT1) on the effect of morphine after major surgery

Detailed description

The purpose of the experiment is to investigate the effect of known genetic variants in organic cation transporter 1 (OCT1) on the effect of morphine after major surgery. This is primarily done by investigating systemic exposure of morphine in a cohort of patients undergoing scheduled laparoscopic colon or laparoscopic rectum surgery, and as pain treatment with intravenous (iv) morphine at the end of and after surgery (primary endpoints). As a secondary endpoint, we will investigate the effect (pharmacodynamics) of morphine in the same patients by registering pain during rest and activity, side effects and the degree of sedation at appropriate time intervals.

Conditions

• Organic Cation Transporter 1
• Morphine

Interventions

Type	Name	Description
DRUG	Morphine	The study was designed as an open, non-controlled drug trial, with scientists and participants blinded to the patients OCT1 status. Morphine will be given as a single dosis (0,15 mg/kg) at the end of the Surgery and later as boluses of 0,04mg/kg administrated by patient-controlled analgesia, (PCA). Blood samples with drug concentrations will be used to determine a difference in morphine AUC due to the patients OCT1 status. Questionnaire answers will be used to determine the effect of morphine due to the patients OCT1 status

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-02-07
• Completion: 2020-02-07
• First posted: 2018-02-07
• Last updated: 2020-06-29

Locations

2 sites across 1 country: Denmark