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

NCT03378960 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-02-25

No results posted yet for this study

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

Interventions

DRUG

Omeprazole 20mg

Sponsors & Collaborators

  • Fundación Mutua Madrileña

    collaborator OTHER

  • Emilio Vargas Castrillón

    lead OTHER

Study Design

Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-12-23
Completion
2016-02-29

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03378960 on ClinicalTrials.gov