NCT03425084

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

June 29, 2020

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

January 15, 2018

Last Update Submit

June 24, 2020

Conditions

Organic Cation Transporter 1Morphine

Outcome Measures

Primary Outcomes (1)

  • Morphine Area under the curve (AUC)

    Difference in morphine AUC due to patient OCT1 status

    Blood samples will be drawn at zero, five, 10, 15, 30, 45, 60 and 90 minutes after the first morphine bolus

Secondary Outcomes (5)

  • Morphine effect

    Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus

  • Morphine effect

    Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus

  • Morphine effect

    Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus

  • Morphine effect

    After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.

  • Morphine effect

    After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.

Study Arms (1)

Morphine

EXPERIMENTAL

Intravenous morphine (0,15 mg/kg) will be given as a single dosis at the end of the surgery followed by morphine administrated by patient-controlled analgesia (PCA) as single boluses (0,04mg/kg)

Drug: Morphine

Interventions

MorphineDRUG

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

Morphine

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned Colectomy / Hemicolectomy, sigmoid resection, rectal resection or abdominal perianal amputation of the rectum with stoma, good general health (ASA 1 -2), Informed consent given, Age 18-90 years and BMI 18,5 - 35kg/m².

You may not qualify if:

  • Abdominoperineal resection (APR) - ad modum Holm (abdominal perianal amputation of rectum with stoma)
  • Daily use of opioids
  • Indicator for the use of an epidural catheter
  • Alcohol abuse
  • Hypersensitivity for morphine
  • A known serious disease (Terminal cancer, severe dementia, significant heart, liver, lung or renal failure or severe psychiatric disease)
  • Women of childbearing age who do not use safe contraception
  • Women who are breastfeeding
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sydvestjysk Sygehus

Esbjerg, 7100, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, phd student

Study Record Dates

First Submitted

January 15, 2018

First Posted

February 7, 2018

Study Start

June 1, 2018

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

June 29, 2020

Record last verified: 2018-01

Locations

DK(2)