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Sustained-release Morphine Pharmacokinetics in Roux-en-Y Gastric Bypass Subjects (OBEMO2)

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ClinicalTrials.gov Identifier: NCT02641301
Recruitment Status : Unknown
Verified November 2016 by Célia Lloret-Linares, MD PhD, Hopital Lariboisière.
Recruitment status was:  Active, not recruiting
First Posted : December 29, 2015
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Célia Lloret-Linares, MD PhD, Hopital Lariboisière

Brief Summary:
The purpose of this study is to determine whether sustained release morphine pharmacokinetics parameters in patients undergone roux-en-y gastric bypass (RYGB) differ from subjects who did not. Our hypothesis is that exposure is comparable. Indeed, in the Study OBEMO (Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass; NCT00943969) the investigators observed changes in pharmacokinetics parameters for immediate release morphine, probably due to an earlier absorption of the morphine, in agreement with the expected clinical effect of this formulation.

Condition or disease Intervention/treatment Phase
Bypass Complications Drug: Sustained release morphine sulfate, 30 mg Phase 4

Detailed Description:
This is an open label study with two arms: patients undergone roux-en-y gastric bypass and volunteers who did not matched by sex, age and Body Mass Index (BMI). In the pharmacokinetic visit the subject takes an oral administration of sustained release morphine, 30 mg, then 11 samples are collected during 12 hours.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Study of the Concentrations of Long Acting Morphine After Oral Absorption in Subjects Who Underwent Gastric Bypass (OBEMO 2)
Study Start Date : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Subjects Roux-en-Y-gastric bypass (RYGB)
Sustained release morphine sulfate, 30 mg
Drug: Sustained release morphine sulfate, 30 mg
A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.
Other Name: Code : 333 236-9 ; Access market authorisation 3400933323691

Active Comparator: Control volunteers matched with RYGB
Sustained release morphine sulfate, 30 mg
Drug: Sustained release morphine sulfate, 30 mg
A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.
Other Name: Code : 333 236-9 ; Access market authorisation 3400933323691




Primary Outcome Measures :
  1. Morphine area under the curve (AUC0-inf) after its oral administration according to the morphine concentration. [ Time Frame: During the study visit: morphine concentration at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after its oral administration ]

Secondary Outcome Measures :
  1. Area under ther curve [AUC] of morphine-3-glucuronide, morphine-6-glucuronide [ Time Frame: During the study visit: concentration at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration ]
  2. Time of the maximum plasma concentration [Tmax] of morphine, morphine-3-glucuronide, morphine-6-glucuronide [ Time Frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration ]
  3. Observed clearance [Cl/F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide [ Time Frame: During the study visit: concentrations at time 0,5h; 1h; 1,5h; 2h; 2,5h; 3h; 4h; 5h; 6h; 8h; 12h after morphine oral administration ]
    Blood samples gathered from hour 0,5 to hour 12 and urine sample gathered from the start to the end of the study visit.

  4. Observed Volume of distribution [Vd / F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide [ Time Frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration ]
  5. Plasma Half-Life [T1 /2] of morphine, morphine-3-glucuronide, morphine-6-glucuronide [ Time Frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration ]
  6. Maximum plasma concentration [Cmax] of morphine, morphine-3-glucuronide, morphine-6-glucuronide [ Time Frame: During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

RYGB Group (n=12) :

  • Subjects who undergone RYGB for at least 24 months
  • 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 20-65 years
  • Written consent

Exclusion Criteria:

  • 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 Prothrombin ratio <70% and/ or aspartate transaminase > 5 times the usual values and/ or alanine aminotransferase >5 times the usual values and/ or in renal function (creatinine clearance Modification of Diet in Renal Disease (MDRD) < 60ml/ min
  • Respiratory insufficiency defined by an oximetry below 90%
  • Pregnancy and breastfeeding
  • Use of drugs contra-indicated or not advised with morphine:
  • Agonists-antagonists opioids ( buprenorphine, nalbuphine, pentazocine ), naltrexone
  • Alcohol intake > 30g by day
  • Cough medicine morphine-like ( dextromethorphan, noscapine, pholcodine )
  • Codeine, ethylmorphine
  • Other morphine agonist ( alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidin, phenoperidine, remifentanil, sufentanil, tramadol )
  • Barbiturates, benzodiazepines
  • Rifampicin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641301


Locations
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France
Therapeutic Research Unit, Department of Internal Medicine, Hospital Lariboisiere
Paris, France, 75010
Hopital Pitie Salpetriere
Paris, France, 75013
Sponsors and Collaborators
Hopital Lariboisière
Investigators
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Study Director: Jean-Francois JB Bergmann, MD, PhD Hopital Lariboisiere

Publications:

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Responsible Party: Célia Lloret-Linares, MD PhD, MD, PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT02641301    
Other Study ID Numbers: OBEMO2
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Célia Lloret-Linares, MD PhD, Hopital Lariboisière:
obesity
Roux-en-Y-gastric bypass
pharmacokinetics
Pain
morphine
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents