Study to Compare the Bioavailability of Omeprazole 20 mg Before and After Undergoing Surgery for Morbid Obesity

NCT03378960 | Completed Phase 4

• 1 other identifier: OBS-2011/001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• AUC 1 month

  1 month after surgery

• Tmax 1 month

  1 month after surgery

• Cmax 1 month

  1 month after surgery

Study Arms (1)

omeprazole

OTHER

omeprazole 20 mg

Drug: Omeprazole 20mg

Interventions

Omeprazole 20mg DRUG

omeprazole

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Emilio Vargas Castrillón: lead
• Fundación Mutua Madrileña: collaborator

Study Sites (1)

Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Clinical Pharmacology Department

Model Details: This was a single-dose, open-label, bioavailability study of surgical group and controls.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 20, 2017
• Study Start: October 31, 2014
• Primary Completion: December 23, 2015
• Study Completion: February 29, 2016
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)