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

NCT ID: NCT03378960

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-02-29

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

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

omeprazole

omeprazole 20 mg

Group Type: OTHER

Omeprazole 20mg

Intervention Type: DRUG

Interventions

Omeprazole 20mg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Mutua Madrileña

OTHER

Sponsor Role: collaborator

Emilio Vargas Castrillón

OTHER

Sponsor Role: lead

Responsible Party

Emilio Vargas Castrillón

Head of Clinical Pharmacology Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Madrid, , Spain

Countries

Spain

Other Identifiers

OBS-2011/001

Identifier Type: -

Identifier Source: org_study_id