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

NCT02641301 | Unknown Phase 4

• 1 other identifier: OBEMO2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Bypass Complications

Keywords

obesity; Roux-en-Y-gastric bypass; pharmacokinetics; Pain; morphine

Outcome Measures

Primary Outcomes (1)

• Morphine area under the curve (AUC0-inf) after its oral administration according to the morphine concentration.

  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 Outcomes (6)

• Area under ther curve [AUC] of morphine-3-glucuronide, morphine-6-glucuronide

  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

• Time of the maximum plasma concentration [Tmax] of morphine, morphine-3-glucuronide, morphine-6-glucuronide

  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

• Observed clearance [Cl/F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide

  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

• Observed Volume of distribution [Vd / F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide

  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

• Plasma Half-Life [T1 /2] of morphine, morphine-3-glucuronide, morphine-6-glucuronide

  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

Study Arms (2)

Subjects Roux-en-Y-gastric bypass (RYGB)

EXPERIMENTAL

Sustained release morphine sulfate, 30 mg

Drug: Sustained release morphine sulfate, 30 mg

Control volunteers matched with RYGB

ACTIVE COMPARATOR

Sustained release morphine sulfate, 30 mg

Drug: Sustained release morphine sulfate, 30 mg

Interventions

Sustained release morphine sulfate, 30 mg DRUG

A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.

Also known as: Code : 333 236-9 ; Access market authorisation 3400933323691

Control volunteers matched with RYGB; Subjects Roux-en-Y-gastric bypass (RYGB)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Lariboisière: lead

Study Sites (2)

Therapeutic Research Unit, Department of Internal Medicine, Hospital Lariboisiere

Paris, 75010, France

Location

Hopital Pitie Salpetriere

Paris, 75013, France

Location

Related Publications (15)

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  PMID: 21478461 BACKGROUND

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  PMID: 14663457 BACKGROUND

MeSH Terms

Conditions

Obesity; Pain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Jean-Francois JB Bergmann, MD, PhD

  Hopital Lariboisiere

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 29, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 29, 2016

Record last verified: 2016-11

Locations

FR (2)