Bariatric Surgery and Pharmacokinetics of Quetiapine
Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT03449472
Collaborator
St. Olavs Hospital (Other), Volvat Medisinsk Senter Stokkan (Other), Namsos Hospital (Other), Alesund Hospital (Other)
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Study Details
Study Description
Brief Summary
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 quetiapine are investigated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
12 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Bariatric Surgery and Pharmacokinetics Quetiapine: BAR-MEDS Quetiapine
Actual Study Start Date
:
Jan 2, 2018
Anticipated Primary Completion Date
:
Oct 1, 2026
Anticipated Study Completion Date
:
Oct 1, 2026
Outcome Measures
Primary Outcome Measures
- Quetiapine concentration in blood serum (area under curve (AUC)) [From baseline to 1 year postoperatively]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Olavs University Hospital | Trondheim | Norway |
Sponsors and Collaborators
- Norwegian University of Science and Technology
- St. Olavs Hospital
- Volvat Medisinsk Senter Stokkan
- Namsos Hospital
- Alesund Hospital
Investigators
- Principal Investigator: Magnus Strømmen, MSc, St. Olavs University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT03449472
Other Study ID Numbers:
- 2016/1145a
First Posted:
Feb 28, 2018
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Norwegian University of Science and Technology
Additional relevant MeSH terms: