Morbid ObesityPhase 4MEMONCT01519726
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug
A Phase 4 study testing Midazolam in people with Morbid Obesity, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2011to Dec 2013
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI>40
- undergoing bariatric surgery
Who cannot join
- use of drug inducing or inhibiting CYP3A4 activity
- pregnancy, breastfeeding
- renl insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CYP3A4 Metabolism Before and After Surgery Induced Weight Loss in Morbidly Obese Patients Using Midazolam as a Model Drug
Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again.
- Conditions
- Morbid Obesity
- Being tested
- Midazolam
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| Morbidly obese patients | Experimental | Not described Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery
Measured: 0.5-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- 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 4
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherijne Knibbe, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519726
- Sponsor's protocol ID
- MEMO study
- Acronym
- MEMO
- Status last verified
- Apr 2019
- First submitted
- 4 Jan 2012
- Last updated
- 4 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CYP3A4 Metabolism Before and After Surgery Induced Weight Loss in Morbidly Obese Patients Using Midazolam as a Model Drug
- ClinicalTrials.gov ID
- NCT01519726
- Acronym / sponsor ID
- MEMO / MEMO study
- Conditions
- Morbid Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jan 2012 (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.
Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morbidly obese patients | Experimental | Drug: Midazolam |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI>40
- undergoing bariatric surgery
Key exclusion criteria (3 listed)
- use of drug inducing or inhibiting CYP3A4 activity
- pregnancy, breastfeeding
- renl insufficiency
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 |
|---|---|---|
| Midazolam | Drug | Morbidly obese patients |
Primary outcome
Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery
Time frame: 0.5-2 years
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 4 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam in people with Morbid Obesity, run by St. Antonius Hospital at 1 site in Netherlands.
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 2 inclusion and 3 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 4 Apr 2019. 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 Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery (time frame: 0.5-2 years). 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 4 Apr 2019.