NCT00277589已完成4 期
TSH-adapted Therapy in a Large Randomized, Observer-blind, Placebo-controlled, Prospective Treatment Study of Patients With Nodular Goiter
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,024
- 试验地点
- 1
- 主要终点
- The primary outcome measure is to compare the change in total volume of all nodules after 12 months Levothyroxin treatment to the change after 12 months of each of the reference treatments (one of the two active controls or placebo)
研究概览
简要总结
Primary objective:
- To evaluate change in total volume of all nodules.
Secondary objectives:
- To evaluate change in goiter volume after a 12-months treatment, number of nodules and echogenicity of nodules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Caucasian
- •Normal TSH value (target range between 0.6 - 3.0 mU/l)
- •Thyroid nodules in a normal sized or enlarged thyroid at least one nodule (smaller/equal 20 % of volume with cystic change) with greater/equal 1.0 cm diameter, for nodules greater 1.0 cm the diagnosis must be performed according to the guideline for diagnostic standards of thyroid disorders.
排除标准
- •Thyroid therapy within the last 3 years
- •Known focal or diffuse structure autonomous thyroid
- •Contraindication to iodine
- •Concomitant treatment with iodine containing medication (i.e. amiodarone)
- •Use of iodine-containing contrast medium within the last 6 weeks
- •Presence of TPO antibodies (maximum two fold normal value)
- •Symptomatic coronary heart disease
- •Endocrine orbitopathy
- •Known autoimmune thyreopathy
- •Former radioiodine therapy or surgery
- •Dermatitis herpetiformis
- •Pathological laboratory results
- •Participation in another clinical study with investigational medication within the last 30 days
- •Pregnant or nursing female patients
- •Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- •Severe or unstable cardiovascular diseases (e.g. severe angina pectoris, postmyocardial infarction syndrome and ventricular extrasystoles, symptomatic coronary heart disease), clinically relevant renal or hepatic diseases or disorders, any other clinically relevant condition that might enhance the risk for the study participant.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: Levothyroxine-Na + iodide (Drug)
2
Active Comparator
干预措施: Levothyroxin-Na (Drug)
3
Active Comparator
干预措施: Iodide (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The primary outcome measure is to compare the change in total volume of all nodules after 12 months Levothyroxin treatment to the change after 12 months of each of the reference treatments (one of the two active controls or placebo)
时间窗: after 12 months of treatment
次要结局
- The change in goitre volume after Levothyroxin treatment will be compared to that after each reference treatment after 12 months treatment.(after 12 months treatment)
- Additionally, the change in the number of nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.(after 12 months treatment)
- Echogenicity of the nodules after Levothyroxin treatment will be compared to each reference treatment after 12 months treatment.(after 12 months treatment)
研究者
研究点 (1)
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