Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

NCT ID: NCT03094416

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2020-06-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

levothyroxine sodium capsules

levothyroxine sodium capsules 88 to 250 mcg/day (depending on individual needs) for 3 months

Group Type: EXPERIMENTAL

levothyroxine sodium capsule

Intervention Type: DRUG

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)

Intervention Type: 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) Tablets

Intervention Type: DRUG

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

Interventions

levothyroxine sodium capsule

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Tirosint; omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, rabeprazole

Eligibility Criteria

Inclusion Criteria

1. written informed consent duly read, signed and dated by the subject;

2. aged ≥18 and ≤65 years;

3. history of hypothyroidism due to total thyroidectomy;

4. on stable LT4 doses for at least 6 weeks at screening (≥88 mcg daily and ≤250 mcg daily);

5. TSH at screening ≥0.3 and ≤4.0 mIU/L;

6. history of gastroesophageal reflux disease or associated gastrointestinal issues on prescription PPIs (i.e. omeprazole ≥20 mg daily, or esomeprazole ≥ 20 mg daily, or lansoprazole ≥ 15 mg daily, or pantoprazole ≥ 40 mg daily) for at least 8 weeks before screening visit and for whom chronic therapy with PPIs for the next 5 months has been prescribed;

7. for women, adequate and continuative contraceptive measures until the end of the study, if not in menopause;

8. reasonable assumption of understanding the study and willingness to take part to the study and to comply with protocol requirements.

Exclusion Criteria

1. suspected or ascertained non-compliance with LT4 or PPI therapy;

2. subject requiring changes of levothyroxine dose;

3. use of over-the-counter (OTC) PPIs;

4. history of malabsorption or history of gastric bypass surgery, short-gut syndrome, inflammatory bowel disease and other conditions of the gastrointestinal tract that may affect drug absorption (e.g. celiac disease)3;

5. multiple co-morbidities (e.g. cardiac heart failure, active arrhythmia or history of arrhythmia, particularly atrial fibrillation, uncompensated diabetes mellitus, uncorrected adrenal insufficiency, seriously compromised hepatic, renal and/or respiratory functions);

6. neoplastic pathology, active or in remission for less than 5 years (excluding the basic thyroid pathology);

7. terminal condition;

8. parenteral or assisted enteral feeding;

9. presence of any medical condition or other circumstances which would significantly affect the safety of the subject or decrease the chance of obtaining reliable data, achieving study objectives or completing the study;

10. history of alcoholism, drug abuse or psychiatric diseases that could invalidate the informed consent or limit the subject compliance with protocol requirements;

11. pregnant (positive urine pregnancy test at screening or baseline visits) or breast-feeding subject or subject planning a pregnancy in the next months;

12. known hypersensitivity to the ingredients of the preparation involved in the study3;

13. use of forbidden concomitant medications;

14. regular consumption of soy and soy derivatives, cotton seed meals, walnuts, and dietary fibres;

15. participation in other clinical studies during the 3 months prior to screening;

16. presumption of poor reliability/cooperation;

17. any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IBSA Institut Biochimique SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth D Burman, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

California Head and Neck Specialists

La Jolla, California, United States

Coastal Metabolic Research Centre

Ventura, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

NYC Health + Hospitals/ Queens

New York, New York, United States

Diabetes & Endocrinology Consultants, PC

Morehead City, North Carolina, United States

Carolina Ear Nose and Throat Clinic

Orangeburg, South Carolina, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Stonesifer Endocrine Care & Clinical Research Inc., PS

Federal Way, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37885233 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

13US-T404

Identifier Type: -

Identifier Source: org_study_id