Study to Compare the Bioavailability of Omeprazole 20 mg Before and After Undergoing Surgery for Morbid Obesity (OBS-2011/001)

Bioavailability Study of Omeprazole (20 mg) at Steady State (Multiple Dose) in Patients Who Have Undergone Bariatric Surgery

The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability of omeprazole 20 mg at one month and six months after surgery.

Other objectives were:

• To compare bioavailability of omeprazole 20 mg between patients undergo gastric bypass surgery and patients who avoid it.
• To asses other pharmacokinetic parameters, demographic parameters and drug safety.

Study design It was planned a mixed design which intended to compare the bioavailability in patients with gastric bypass (before and after surgery) and control subjects matched by sex and body mass index (BMI) post-surgery. This was a single-dose, open-label, crossover bioavailability study of omeprazole in surgical group and controls.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Drug: Omeprazole 20mg

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who wish to participate in the study (men and women) after receiving adequate information about the study design, objectives and risks by signing and date of the written informed consent.
• Age between 18 and 60 years old.
• Patients who come to the endocrinology and nutrition Service and on treatment with omeprazole.
• Patients who are to undergo bariatric surgery (Roux en Y gastric bypass) according to the recommendations of Endocrinology and Nutrition Service and the Department of General Surgery and Digestive Diseases hospital Clinico San Carlos.
• No significant abnormalities on clinical examination and laboratory analysis before inclusion in the study.

Exclusion Criteria:

• Any postoperative complication that interferes with the regular intake of medication such as stenosis of anastomotic, fistula, persistent vomiting, diarrhea (> 4 stools per day), evidence of protein malnutrition (albumin <3.5 g / l).
• High consumption of stimulating beverages (equivalent to 400 mg of caffeine per day, a cup of coffee contains approximately 100 mg of caffeine).
• Consumption of any medication that may interfere with the objectives of the study: * Use of enzyme inhibitors or inducers within 2 weeks prior to study inclusion (barbiturates, carbamazepine, erythromycin, phenytoin, oral contraceptives, etc.) * Any concomitant medication will be assessed by the investigator based on data recorded in the log-book for the medication (potential interactions) and registered in the CRF.
• History of clinically significant disease in the opinion of the investigator does not allow safe participation of the patient.
• Inability to relate to and / or cooperate with investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: omeprazole; omeprazole 20 mg	Drug: Omeprazole 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC variation Pharmacokinetic parameters	Omeprazole Biodisponibility	Baseline and 6 month after bariatric surgery
Tmax variation	Time required to reach the maximum concentration of Omeprazole in blood after its administration.	Baseline and 6 month after bariatric surgery
Cmax variation	Maximum concentration of Omeprazole in blood after its administration.	Baseline and 6 month after bariatric surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC 1 month	Omeprazole Biodisponibility	1 month after surgery
Tmax 1 month	Time required to reach the maximum concentration of Omeprazole in blood after its administration	1 month after surgery
Cmax 1 month	Maximum concentration of Omeprazole in blood after its administration.	1 month after surgery

Collaborators and Investigators

• Sponsor: Emilio Vargas Castrillón
• Collaborators: Fundación Mutua Madrileña

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2014
• Primary Completion (Actual): December 23, 2015
• Study Completion (Actual): February 29, 2016

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: OBS-2011/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No