Opioid Use, Unspecified With Other Opioid-induced DisorderPhase 1RELZH12NCT01889290
Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients
A Phase 1 study testing Methylnaltrexone in people with Opioid Use, Unspecified With Other Opioid-induced Disorder, run by University of Zurich at 1 site in Switzerland.
Trial summary
Assessment of pharmacokinetic parameters of once daily subcutaneously administered methylnaltrexone in 10 evaluable neurointensive care patients. Quantification of methylnaltrexone passage through the blood-brain-barrier in critically ill patients with severe cerebral affections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Unspecified With Other Opioid-induced Disorder
- What is being tested?
- Methylnaltrexone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Jun 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalisation in the neurointensive care unit
- deep sedation with sufentanil doses of = 40 mcg/h
- male or female aged 18 years or older
- females: negative pregnancy test
- Ventricular drainage as part of needed therapeutic measures
Who cannot join
- History of hypersensitivity to methylnaltrexone (Relistor®)
- confirmed or suspected obstructive ileus or factors possibly leading to intestinal obstruction (e.g. an intestinal tumor)
- increased risk for patients with localized or diffused reduction in structural integrity of the gastrointestinal tract (e.g. peptic ulcer, acute diverticulitis)
- severe hepatic insufficiency (Child-Pugh Class C)
- renal impairment (glomerular filtration rate < 90 ml/min) with or without renal replacement therapy
- severe diarrhea despite high opioid dosing
- participation in another study with an investigational drug within the 30 days preceding and during the present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Once Daily Subcutaneous Methylnaltrexone in Neurointensive Care Patients With High Dose Sufentanil Analgosedation
- Assessment of pharmacokinetic parameters of once daily subcutaneously administered methylnaltrexone in 10 evaluable neurointensive care patients.
- Quantification of methylnaltrexone passage through the blood-brain-barrier in critically ill patients with severe cerebral affections.
- Observation of laxation response after methylnaltrexone application and relation to plasma concentrations of methylnaltrexone.
- Assessing the safety of once daily administered methylnaltrexone in neurointensive care patients.
- Trial with medicinal product
Read the detailed description
After administration of methylnaltrexone s.c. multiple peripheral blood samples and additionally two liquor samples are drawn during a dose interval on day 1, 3, and 5 of drug administration.
- Being tested
- Methylnaltrexone
- Keywords
- methylnaltrexone, opioid-antagonist, Obstipation, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylnaltrexoneDrug
Also called Relistor
Methylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl
| Study group | Role | What they receive |
|---|---|---|
| Methylnaltrexone | Experimental | Pharmacokinetics of methylnaltrexone administered once daily Receives: Drug: Methylnaltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use, Unspecified With Other Opioid-induced DisorderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natascia Corti, MD, Principal investigator, University Hospital Zurich, Pharmacology and Toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889290
- Sponsor's protocol ID
- RELZH12
- Acronym
- RELZH12
- Status last verified
- Oct 2016
- First submitted
- 17 Jun 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Once Daily Subcutaneous Methylnaltrexone in Neurointensive Care Patients With High Dose Sufentanil Analgosedation
- ClinicalTrials.gov ID
- NCT01889290
- Acronym / sponsor ID
- RELZH12 / RELZH12
- Keywords
- methylnaltrexone, opioid-antagonist, Obstipation, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Jun 2013 (estimated)
- 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.
- Assessment of pharmacokinetic parameters of once daily subcutaneously administered methylnaltrexone in 10 evaluable neurointensive care patients.
- Quantification of methylnaltrexone passage through the blood-brain-barrier in critically ill patients with severe cerebral affections.
- Observation of laxation response after methylnaltrexone application and relation to plasma concentrations of methylnaltrexone.
- Assessing the safety of once daily administered methylnaltrexone in neurointensive care patients.
- Trial with medicinal product
Detailed description
After administration of methylnaltrexone s.c. multiple peripheral blood samples and additionally two liquor samples are drawn during a dose interval on day 1, 3, and 5 of drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylnaltrexone | Experimental | Drug: MethylnaltrexonePharmacokinetics of methylnaltrexone administered once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hospitalisation in the neurointensive care unit
- deep sedation with sufentanil doses of = 40 mcg/h
- male or female aged 18 years or older
- females: negative pregnancy test
- Ventricular drainage as part of needed therapeutic measures
Key exclusion criteria (7 listed)
- History of hypersensitivity to methylnaltrexone (Relistor®)
- confirmed or suspected obstructive ileus or factors possibly leading to intestinal obstruction (e.g. an intestinal tumor)
- increased risk for patients with localized or diffused reduction in structural integrity of the gastrointestinal tract (e.g. peptic ulcer, acute diverticulitis)
- severe hepatic insufficiency (Child-Pugh Class C)
- renal impairment (glomerular filtration rate < 90 ml/min) with or without renal replacement therapy
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 |
|---|---|---|
| MethylnaltrexoneAlso: RelistorMethylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl | Drug | Methylnaltrexone |
Primary outcome
Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance)
Time frame: 5 days
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 26 Oct 2016.
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.
Natascia Corti, MD principal investigator
University Hospital Zurich, Pharmacology and Toxicology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methylnaltrexone in people with Opioid Use, Unspecified With Other Opioid-induced Disorder, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 7 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance) (time frame: 5 days). 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 26 Oct 2016.