- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03425084
Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics
June 24, 2020 updated by: Ida Kuhlmann, University of Southern Denmark
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Esbjerg, Denmark, 7100
- Sydvestjysk Sygehus
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Odense, Denmark, 5000
- Odense Universitetshospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Morphine
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)
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine Area under the curve (AUC)
Time Frame: Blood samples will be drawn at zero, five, 10, 15, 30, 45, 60 and 90 minutes after the first morphine bolus
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Difference in morphine AUC due to patient OCT1 status
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Blood samples will be drawn at zero, five, 10, 15, 30, 45, 60 and 90 minutes after the first morphine bolus
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine effect
Time Frame: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
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Pain during rest and activity will be evaluated through a Numeric Rating Scale on the same patients where 0 is no pain and 10 is the the worst possible pain.
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Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
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Morphine effect
Time Frame: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
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side effects will be evaluated through a 5-point verbal questionnaire on the same patients where 0 is no side effects and 4 is unacceptable side effects.
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Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
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Morphine effect
Time Frame: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
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The degree of sedation will be evaluated through the Richmond Agitation and Sedation Scale (RASS) on the same patients
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Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
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Morphine effect
Time Frame: After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.
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The total dose of morphine used during the investigation.
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After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.
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Morphine effect
Time Frame: After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.
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The number of administrations of morphine will be recorded
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After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2018
Primary Completion (ACTUAL)
February 7, 2020
Study Completion (ACTUAL)
February 7, 2020
Study Registration Dates
First Submitted
January 15, 2018
First Submitted That Met QC Criteria
February 6, 2018
First Posted (ACTUAL)
February 7, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 29, 2020
Last Update Submitted That Met QC Criteria
June 24, 2020
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKF-391
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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