CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 66 enrolled
Drug / intervention
levothyroxine sodium capsule +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03094416
NCT03094416Phase 4Completed
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An Open-label Therapeutic Efficacy Study of Tirosint (Levothyroxine Sodium) Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors

IBSA Institut Biochimique SA·interventional·Posted Mar 29, 2017·Updated Apr 5, 2022

In Brief

A Phase 4 clinical trial evaluating levothyroxine sodium capsule, Proton pump inhibitor (PPI), and 1 other intervention for Hypothyroidism;Postablative. Completed, enrolled 66 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypothyroidism;Postablative
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 29, 2017
Enrollment StartJul 30, 2018
Primary CompletionJun 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.3 years ago

Interventions

levothyroxine sodium capsuledrug

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

Proton pump inhibitor (PPI)drug

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

Levothyroxine Sodium (LT4) Tabletsdrug

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