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Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

NCT03094416 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-04-05

Study results available
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Summary

This is an open-label therapeutic efficacy study of Tirosint (levothyroxine sodium) capsules in thyroidectomized patients taking proton pump inhibitors and levothyroxine, evaluating changes in serum levels of Thyroid Stimulating Hormone (TSH) upon switch to Tirosint with respect to baseline.

Conditions

  • Hypothyroidism;Postablative

Interventions

DRUG

levothyroxine sodium capsule

after the run-in period, patients will be switched to levothyroxine sodium capsule at the same dose used during run-in

DRUG

Proton pump inhibitor (PPI)

for the whole study duration all subjects will keep taking their proton pump inhibitor medication, as per prescription and as before inclusion

DRUG

Levothyroxine Sodium (LT4) Tablets

during the run-in period, subjects will continue taking their levothyroxine sodium tablet medication as per prescription and as before inclusion

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Principal Investigators

  • Kenneth D Burman, MD · Medstar Health Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-30
Primary Completion
2020-06-15
Completion
2020-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03094416 on ClinicalTrials.gov