Subjects volunteers who undergone Roux-en-Y gastric bypass (RYGB) for at least 48 months and control subjects matched for BMI, age and sex
Conditions
Interventions
Trade Name: ORAMORPH
Product Name: ORAMORPH 30 mg/5 ml
Pharmaceutical Form: Oral solution in single-dose container
Sponsors
Therapeutic Research Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: RYGB Group (n=12) -Subjects who undergone RYGB for at least 48 months included in OBEMO1 ans OBEMO2 - Stable weight since almost one year (or weight loss below 10kg over the last year) Control group (n=12) -Volunteers subjects, matched for age, sex, and Body mass index -No history of bariatric surgery Same characteristics -Subjects volunteers for the study -Age 20-70 years -Written consent - Drug addiction score according to criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: - Individuals under the protection of a conservaor, curatorship, guardianship -Uncontrolles seizures -Known allergy to morphine or naloxone -Patients not affiliated to the french social security system. -Subjects yet recruited in a study with remuneration -Abnormalities in liver function (TP5N and/or ALAT>5N) and/or in renal function (creatinine clearance MDRD 30g by day •Cough medicine morphine-like (dextromethorphan, noscapin, pholcodin) • Codeine, éthylmorphine •Other morphine agonists (alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidin, phenoperidin, remifentanil, sufentanil, tramadol) •Barbiturates, Benzodiazepines. •Rifampicin - Drug addiction score according to criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) = 2 Morphine/ opiate addiction or abuse, or history of morphine/ opiate addiction or abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare morphine exposition (AUC0-inf) after oral administration of immediate release morphine sulfate, 30mg, in patients who undergone Roux-en-Y Gastric Bypass with morphine exposition in patients who did not, matched for age, sex and Body Mass Index.;Secondary Objective: To compare the other pharmacokinetics parameters of morphine and morphine metabolites, M3G and M6G, between RYGB and control populations (Cmax, Tmax, Cl/F, Vdz/F, clearance et T1/2 et AUC 0-inf). Specify morphine pharmacokinetic parameters evolution from before surgery, at 1-2 weeks, 6 months and 48 years after surgery;Primary end point(s): To compare morphine exposition (AUC0-inf) after oral administration of immediate release morphine sulfate, 30mg, in patients who undergone bariatric surgery with morphine exposition in patients who did not, matched for age, sex and Body Mass Index.;Timepoint(s) of evaluation of this end point: plasma samples are collected before and at 5min; 15min; 30 min; 45 min; 1h; 2h; 3h; 4h; 6h; 8h; 10 h after administration of morphine; one time during the study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Other pharmacokinetic parameters of morphine and its metabolites M3G and M6G (Cmax, Tmax, Cl/F, Vdz/F, clearance, T1/2 and AUC0-inf) in both study group and other pharmacokinetics parameters gotten in these patients in OBEMO1 study.;Timepoint(s) of evaluation of this end point: plasma samples are collected at T0 – 5min – 15min – 30 min – 45 min – 1h – 2h – 3h – 4h –6h – 8h – 10 h after administration of morphine; one time during the study visit Urine sample collected during the study visit from the time of administration of morphine to T10h | — |
Countries
France
Contacts
Public ContactLLORET-LINARES
Therapeutic Research Unit
Outcome results
None listed