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Study to Compare the Bioavailability (Amount of Drug Reaching the Blood) of Omeprazole 20 mg Before and After Undergoing Surgery for Morbid Obesity (OBS-2011/001)

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ClinicalTrials.gov Identifier: NCT03378960
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Collaborator:
Fundación Mutua Madrileña
Information provided by (Responsible Party):
Emilio Vargas Castrillón, Hospital San Carlos, Madrid

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.


Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Drug: Omeprazole 20mg Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Sequential Assignment
Intervention Model Description: This was a single-dose, open-label, bioavailability study of surgical group and controls.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Bioavailability Study of Omeprazole (20 mg) at Steady State (Multiple Dose) in Patients Who Have Undergone Bariatric Surgery
Actual Study Start Date : October 31, 2014
Actual Primary Completion Date : December 23, 2015
Actual Study Completion Date : February 29, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
omeprazole
omeprazole 20 mg
Drug: Omeprazole 20mg



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378960


Locations
Spain
Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
Emilio Vargas Castrillón
Fundación Mutua Madrileña

Responsible Party: Emilio Vargas Castrillón, Head of Clinical Pharmacology Department, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT03378960     History of Changes
Other Study ID Numbers: OBS-2011/001
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action