Clinical trial NCT03094416: Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors
Official title: An Open-label Therapeutic Efficacy Study of Tirosint (Levothyroxine Sodium) Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothyroidism;Postablative
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2017-03-29
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Thyroid Stimulating Hormone (TSH)
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Free Thyroxine (FT4)
timeFrame: baseline and 12 weeks
measure: Total Thyroxine (TT4)
timeFrame: baseline and 12 weeks
measure: Free Triiodothyronine (FT3)
timeFrame: baseline and 12 weeks
measure: Total Triiodothyronine (TT3)
timeFrame: baseline and 12 weeks
Other outcomes:
measure: Creatine Phosphokinase (CPK)
timeFrame: baseline and 12 weeks
measure: Sex Hormone Binding Globulin (SHBG)
timeFrame: baseline and 12 weeks
measure: Ferritin
timeFrame: baseline and 12 weeks
measure: Angiotensin Converting Enzyme (ACE)
timeFrame: baseline and 12 weeks
measure: Triglycerides
timeFrame: baseline and 12 weeks
measure: Cholesterol, Total
timeFrame: baseline and 12 weeks
measure: Low Density Lipoprotein (LDL)-Cholesterol
timeFrame: baseline and 12 weeks
measure: High Density Lipoprotein (HDL)-Cholesterol
timeFrame: baseline and 12 weeks
measure: Very Low Density Lipoprotein (VLDL)-Cholesterol
timeFrame: baseline and 12 weeks
Locations:
city: La Jolla
country: United States
facility: California Head and Neck Specialists
state: California
city: Ventura
country: United States
facility: Coastal Metabolic Research Centre
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: New York
country: United States
facility: NYC Health + Hospitals/ Queens
state: New York
city: Morehead City
country: United States
facility: Diabetes & Endocrinology Consultants, PC
state: North Carolina
city: Orangeburg
country: United States
facility: Carolina Ear Nose and Throat Clinic
state: South Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Federal Way
country: United States
facility: Stonesifer Endocrine Care & Clinical Research Inc., PS
state: Washington
Study officials:
affiliation: Medstar Health Research Institute
name: Kenneth D Burman, MD
role: PRINCIPAL_INVESTIGATOR
References: