Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypothyroidism;Postablative

Intervention / Treatment
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* Drug: levothyroxine sodium capsule
* Drug: Proton pump inhibitor (PPI)
* Drug: Levothyroxine Sodium (LT4) Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent duly read, signed and dated by the subject; aged ≥18 and ≤65 years; history of hypothyroidism due to total thyroidectomy; on stable LT4 doses for at least 6 weeks at screening (≥88 mcg daily and ≤250 mcg daily); TSH at screening ≥0.3 and ≤4.0 mIU/L; 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; for women, adequate and continuative contraceptive measures until the end of the study, if not in menopause; reasonable assumption of understanding the study and willingness to take part to the study and to comply with protocol requirements. Exclusion Criteria: suspected or ascertained non-compliance with LT4 or PPI therapy; subject requiring changes of levothyroxine dose; use of over-the-counter (OTC) PPIs; 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; 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); neoplastic pathology, active or in remission for less than 5 years (excluding the basic thyroid pathology); terminal condition; parenteral or assisted enteral feeding; 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; history of alcoholism, drug abuse or psychiatric diseases that could invalidate the informed consent or limit the subject compliance with protocol requirements; pregnant (positive urine pregnancy test at screening or baseline visits) or breast-feeding subject or subject planning a pregnancy in the next months; known hypersensitivity to the ingredients of the preparation involved in the study3; use of forbidden concomitant medications; regular consumption of soy and soy derivatives, cotton seed meals, walnuts, and dietary fibres; participation in other clinical studies during the 3 months prior to screening; presumption of poor reliability/cooperation; any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: levothyroxine sodium capsules<br>levothyroxine sodium capsules 88 to 250 mcg/day (depending on individual needs) for 3 months | Drug: levothyroxine sodium capsule<br>* after the run-in period, patients will be switched to levothyroxine sodium capsule at the same dose used during run-in<br>* Other names: Tirosint;Drug: Proton pump inhibitor (PPI)<br>* for the whole study duration all subjects will keep taking their proton pump inhibitor medication, as per prescription and as before inclusion<br>* Other names: omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, rabeprazole;Drug: Levothyroxine Sodium (LT4) Tablets<br>* during the run-in period, subjects will continue taking their levothyroxine sodium tablet medication as per prescription and as before inclusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroid Stimulating Hormone (TSH) | Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free Thyroxine (FT4) | Change in Serum Levels of FT4 (free thyroxine) from Baseline | baseline and 12 weeks | 
| Total Thyroxine (TT4) | Change in Serum Levels of TT4 (total thyroxine) from Baseline | baseline and 12 weeks | 
| Free Triiodothyronine (FT3) | Change in Serum Levels of FT3 (free triiodothyronine) from Baseline | baseline and 12 weeks | 
| Total Triiodothyronine (TT3) | Change in Serum Levels of TT3 (total triiodothyronine) from Baseline | baseline and 12 weeks |