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Completed

NCT Number: NCT03378960

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omeprazole 20mg

Drug

Primary outcomes

  1. AUC variation Pharmacokinetic parameters

    Time frame: Baseline and 6 month after bariatric surgery

    Omeprazole Biodisponibility

  2. Tmax variation

    Time frame: Baseline and 6 month after bariatric surgery

    Time required to reach the maximum concentration of Omeprazole in blood after its administration.

  3. Cmax variation

    Time frame: Baseline and 6 month after bariatric surgery

    Maximum concentration of Omeprazole in blood after its administration.

Secondary outcomes

  1. AUC 1 month

    Time frame: 1 month after surgery

    Omeprazole Biodisponibility

  2. Tmax 1 month

    Time frame: 1 month after surgery

    Time required to reach the maximum concentration of Omeprazole in blood after its administration

  3. Cmax 1 month

    Time frame: 1 month after surgery

    Maximum concentration of Omeprazole in blood after its administration.

Sponsors and collaborators

Lead sponsor

Emilio Vargas Castrillón

Other

Collaborators

  • Fundación Mutua Madrileña

Registry information

Official study title

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

Acronym: OBS-2011/001

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 20, 2017
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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