NCT03094416已完成4 期
An Open-label Therapeutic Efficacy Study of Tirosint (Levothyroxine Sodium) Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 9
- 主要终点
- Thyroid Stimulating Hormone (TSH)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
levothyroxine sodium capsules
Experimental
levothyroxine sodium capsules 88 to 250 mcg/day (depending on individual needs) for 3 months
干预措施: levothyroxine sodium capsule (Drug)
levothyroxine sodium capsules
Experimental
levothyroxine sodium capsules 88 to 250 mcg/day (depending on individual needs) for 3 months
干预措施: Proton pump inhibitor (PPI) (Drug)
levothyroxine sodium capsules
Experimental
levothyroxine sodium capsules 88 to 250 mcg/day (depending on individual needs) for 3 months
干预措施: Levothyroxine Sodium (LT4) Tablets (Drug)
结局指标
主要结局
Thyroid Stimulating Hormone (TSH)
时间窗: baseline and 12 weeks
Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline
次要结局
- Free Thyroxine (FT4)(baseline and 12 weeks)
- Total Thyroxine (TT4)(baseline and 12 weeks)
- Free Triiodothyronine (FT3)(baseline and 12 weeks)
- Total Triiodothyronine (TT3)(baseline and 12 weeks)
研究者
研究点 (9)
Loading locations...
相似试验
已完成
1 期
Bioavailability of Tiotropium + Olodaterol Fixed-dose Combination (5 μg/ 5 μg) in Chinese COPD PatientsPulmonary Disease, Chronic ObstructiveNCT02969317Boehringer Ingelheim12
已完成
1 期
Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule,Zephir Inhaler DeviceCOPDNCT06254664Xiromed LLC116
已完成
不适用
Supplemental Thyroxine Treatment for Preterm Infants With HypothyroxinemiaHypothyroxinemiaNCT00565890Tokyo Women's Medical University100
Unknown
不适用
Evaluate the Efficacy of TIRZEPATIDE for the Treatment of Moderate to Severe HS Hidradenitis SuppurativaHidradenitis SuppurativaNCT06301256Florida Academic Centers Research and Education, LLC20
已完成
4 期
Efficacy of Tiotropium in Patients of African Descent With Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic ObstructiveNCT00106821Boehringer Ingelheim166