Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

Phase 4 Completed 66 enrolled IBSA Institut Biochimique SA

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2018-07-30
Primary completion: 2020-06-15
Completion: 2020-06-15

Publications

Sachmechi I, Lucas KJ, Stonesifer LD, Ansley JF, Sack P, Celi FS, Scarsi C, Lanzi G, Wartofsky L, Burman KD. Efficacy of Levothyroxine Sodium Soft Gelatin Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors: An Open-Label Study. Thyroid. 2023 Dec;33(12):1414-1422. doi: 10.1089/thy.2023.0382. Epub 2023 Nov 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levothyroxine	Other / unclassified	88 ug	—
Subject	Levothyroxine	Other / unclassified	250 ug	—
Background	Dexlansoprazole	Other / unclassified	—	—
Background	Esomeprazole	Small molecule	—	—
Background	Lansoprazole	Other / unclassified	—	—
Background	Omeprazole	Other / unclassified	—	—
Background	Pantoprazole	Other / unclassified	—	—
Background	Rabeprazole	Small molecule	—	—

Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

Summary

Timeline

Publications

Drugs

Indications