Organic Cation Transporter 1Phase 1NCT03425084
Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics
A Phase 1 study testing Morphine in people with Organic Cation Transporter 1 and Morphine, run by University of Southern Denmark at 2 sites in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Organic Cation Transporter 1, Morphine
- What is being tested?
- Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jun 2018to 7 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- Women of childbearing age who do not use safe contraception
- Women who are breastfeeding
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Sydvestjysk Sygehus
Esbjerg, 7100
Odense Universitetshospital
Odense, 5000
About this study
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
Read the 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
- Being tested
- Morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Area under the curve (AUC)
Difference in morphine AUC due to patient OCT1 status
Measured: 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
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.
Measured: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
Morphine effect
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.
Measured: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
Morphine effect
The degree of sedation will be evaluated through the Richmond Agitation and Sedation Scale (RASS) on the same patients
Measured: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
Morphine effect
The total dose of morphine used during the investigation.
Measured: After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.
Morphine effect
The number of administrations of morphine will be recorded
Measured: After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start1 Jun 2018
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organic Cation Transporter 1Studies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Council for Independent Research, The Faculty of Health Sciences SDU, Region of Southern Denmark
- Responsible party
- Principal investigator, Ida Kuhlmann, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425084
- Sponsor's protocol ID
- AKF-391
- Status last verified
- Jan 2018
- First submitted
- 15 Jan 2018
- Last updated
- 29 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics
- ClinicalTrials.gov ID
- NCT03425084
- Acronym / sponsor ID
- AKF-391
- Conditions
- Organic Cation Transporter 1, Morphine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Council for Independent Research, The Faculty of Health Sciences SDU, Region of Southern Denmark
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morphine | Experimental | Drug: MorphineIntravenous 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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineThe 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 | Drug | Morphine |
Primary outcome
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
Difference in morphine AUC due to patient OCT1 status
5 secondary outcomes
Morphine effect
Time frame: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
Morphine effect
Time frame: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
Morphine effect
Time frame: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus
Morphine effect
Time frame: After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.
Morphine effect
Time frame: After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Morphine in people with Organic Cation Transporter 1 and Morphine, run by University of Southern Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020; AzTrials last refreshed its copy on 6 Nov 2026.