NCT03094416

Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

An Open-label Therapeutic Efficacy Study of Tirosint (Levothyroxine Sodium) Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-07-30
• Primary completion: 2020-06-15
• Completion: 2020-06-15
• First posted: 2017-03-29
• Last updated: 2022-04-05
• Results posted: 2022-04-05

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study