Bariatric Surgery and Pharmacokinetics of Atomoxetine

June 23, 2025 updated by: Norwegian University of Science and Technology

Bariatric Surgery and Pharmacokinetics of Atomoxetine: BAR-MEDS Atomoxetine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on atomoxetine are investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St. Olavs University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Description

Inclusion Criteria:

  • Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
  • Being a Norwegian citizen

Exclusion Criteria:

  • Having previously undergone resections in the GI-tract

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Atomoxetine concentration in blood serum (area under curve (AUC))
Time Frame: From baseline to 1 year postoperatively
From baseline to 1 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
Alesund Hospital
Namsos Hospital
Volvat Medisinsk Senter Stokkan

Investigators

  • Principal Investigator: Magnus Strømmen, MSc, St. Olavs University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2016

Primary Completion (Actual)

March 3, 2020

Study Completion (Actual)

March 3, 2020

Study Registration Dates

First Submitted

March 4, 2018

First Submitted That Met QC Criteria

March 4, 2018

First Posted (Actual)

March 9, 2018

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1145f

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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