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

Bariatric Surgery Candidate Clinical Trial

— OBS-2011/001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378960
• Other study ID #: OBS-2011/001
• Status: Completed
• Phase: Phase 4
• Start date: October 31, 2014
• Est. completion date: February 29, 2016

Study information

• Verified date: February 2019
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 29, 2016
• Est. primary completion date: December 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Drug:
• Omeprazole 20mg

Locations

Country	Name	City	State
Spain	Fundacion para Investigación Biomedica Hospital Clinico San Carlos	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Emilio Vargas Castrillón	Fundación Mutua Madrileña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC variation Pharmacokinetic parameters	Omeprazole Biodisponibility	Baseline and 6 month after bariatric surgery
Primary	Tmax variation	Time required to reach the maximum concentration of Omeprazole in blood after its administration.	Baseline and 6 month after bariatric surgery
Primary	Cmax variation	Maximum concentration of Omeprazole in blood after its administration.	Baseline and 6 month after bariatric surgery
Secondary	AUC 1 month	Omeprazole Biodisponibility	1 month after surgery
Secondary	Tmax 1 month	Time required to reach the maximum concentration of Omeprazole in blood after its administration	1 month after surgery
Secondary	Cmax 1 month	Maximum concentration of Omeprazole in blood after its administration.	1 month after surgery