ObesityPhase 4OBEMONCT00943969
Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass
A Phase 4 study testing gastric bypass in people with Obesity, run by Hopital Lariboisière at 1 site in France.
Trial summary
The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the most frequently surgical methods performed and combines restrictive and malabsorptive procedures. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Jan 2010
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18 and 60 years old.
- Patients with morbid obesity (IMC > 40 kg/m²) or severe obesity (IMC=35-40 kg/m²) with co morbidities (sleep apnea syndrome or hypertension or steatosis hepatitis) with a favourable decision of a multidisciplinary team for a gastric bypass.
- Patient agreeing to go 3 times for a one day hospitalisation in the URT of the Lariboisière Hospital for the morphine PK/PD.
- Patient with a previous medical examination.
- Patient giving its well-informed and free consent after information.
Who cannot join
- diabetes
- concomitant sedative, antidepressive or analgesic treatments or drugs unadvised with morphine
- untreated sleep apnea syndrom, hypoxia (PaO2<70mmHg) or hypercapnia (PaCO2>45mmHg), anaemia <10g/dL, ASAT or ALAT>3N
Trial locations and contacts
1 site in 1 country.
France1 site
Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital
Paris, 75475
About this study
The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the most frequently surgical methods performed and combines restrictive and malabsorptive procedures. Different data suggest that this surgery may modify drug absorption and we think it would be clinically relevant to describe the consequences of gastric bypass on drug systemic exposure in obese patients, since no data on the comparison between the pharmacokinetics (PK) of a drug before and after surgery are available and help to predict the drugs posology.The investigators decided to study the morphine because there is a lack of information about the PK, pharmacodynamics (PD) et pharmacogenetics (PG) of morphine in obese subjects, in contrary with anaesthetic drugs. This is a drug with a narrow therapeutic range frequently prescribed in obese patients.
- Conditions
- Obesity
- Being tested
- gastric bypass
- Keywords
- obesity, gastric bypass, morphine, pharmacokinetic, absorption
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric bypassProcedure or surgery
gastric bypass combines restrictive and malabsorptive procedures
| Study group | Role | What they receive |
|---|---|---|
| obemo | Other | Not described Receives: Procedure: gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
30mg Oral morphine systemic exposure (AUC 0-24)
Measured: Before surgery-7-15 days after surgery- 6 months after surgery
Secondary outcomes (4)
Morphine and M6G AUC, clearance, Cmax and Tmax
Measured: Before surgery-7-15 days after surgery- 6 months after surgery
fat mass and total body water (assessed by DEXA and BIA)
Measured: before surgery and 6 months following surgery
mRNA and protein expression of P-gp , UGT2B7, MRP2 and MRP3 in intestinal biopsies
Measured: obtained from the bariatric surgery
genetic polymorphisms known to affect expression and/or activity of enzymes, receptors and transporters involved in morphine PK/PD (UGT2B7, P-gp, OPRM1, COMT) and morphine PK/PD
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Célia LLORET LINARES, Hopital Lariboisière
- Investigators
- Célia LLoret Linares, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943969
- Sponsor's protocol ID
- CPP 0911965
- Acronym
- OBEMO
- Status last verified
- Dec 2015
- First submitted
- 21 Jul 2009
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass
- ClinicalTrials.gov ID
- NCT00943969
- Acronym / sponsor ID
- OBEMO / CPP 0911965
- Conditions
- Obesity
- Keywords
- obesity, gastric bypass, morphine, pharmacokinetic, absorption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 Jul 2009 (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.
The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the most frequently surgical methods performed and combines restrictive and malabsorptive procedures. Different data suggest that this surgery may modify drug absorption and we think it would be clinically relevant to describe the consequences of gastric bypass on drug systemic exposure in obese patients, since no data on the comparison between the pharmacokinetics (PK) of a drug before and after surgery are available and help to predict the drugs posology.The investigators decided to study the morphine because there is a lack of information about the PK, pharmacodynamics (PD) et pharmacogenetics (PG) of morphine in obese subjects, in contrary with anaesthetic drugs. This is a drug with a narrow therapeutic range frequently prescribed in obese patients.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obemo | Other | Procedure: gastric bypass |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged between 18 and 60 years old.
- Patients with morbid obesity (IMC > 40 kg/m²) or severe obesity (IMC=35-40 kg/m²) with co morbidities (sleep apnea syndrome or hypertension or steatosis hepatitis) with a favourable decision of a multidisciplinary team for a gastric bypass.
- Patient agreeing to go 3 times for a one day hospitalisation in the URT of the Lariboisière Hospital for the morphine PK/PD.
- Patient with a previous medical examination.
- Patient giving its well-informed and free consent after information.
Key exclusion criteria (3 listed)
- diabetes
- concomitant sedative, antidepressive or analgesic treatments or drugs unadvised with morphine
- untreated sleep apnea syndrom, hypoxia (PaO2<70mmHg) or hypercapnia (PaCO2>45mmHg), anaemia <10g/dL, ASAT or ALAT>3N
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 |
|---|---|---|
| gastric bypassgastric bypass combines restrictive and malabsorptive procedures | Procedure or surgery | obemo |
Primary outcome
30mg Oral morphine systemic exposure (AUC 0-24)
Time frame: Before surgery-7-15 days after surgery- 6 months after surgery
4 secondary outcomes
Morphine and M6G AUC, clearance, Cmax and Tmax
Time frame: Before surgery-7-15 days after surgery- 6 months after surgery
fat mass and total body water (assessed by DEXA and BIA)
Time frame: before surgery and 6 months following surgery
mRNA and protein expression of P-gp , UGT2B7, MRP2 and MRP3 in intestinal biopsies
Time frame: obtained from the bariatric surgery
genetic polymorphisms known to affect expression and/or activity of enzymes, receptors and transporters involved in morphine PK/PD (UGT2B7, P-gp, OPRM1, COMT) and morphine PK/PD
Time frame: Before surgery
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 16 Dec 2015.
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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.
Célia LLoret Linares principal investigator
Assistance Publique - Hôpitaux de Paris
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 gastric bypass in people with Obesity, run by Hopital Lariboisière at 1 site in France.
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 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 16 Dec 2015. 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 France. 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?
30mg Oral morphine systemic exposure (AUC 0-24) (time frame: Before surgery-7-15 days after surgery- 6 months after surgery). 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 16 Dec 2015.