EUCTR2016-004078-16-SE进行中（未招募）1 期
A dose-response study of markers of glucocorticoid action (DOSCORT)-A double-blind, randomized, two-period, two-dose, cross-over study in subjects with primary adrenal insufficiency - DOSCORT
Sahlgrenska University Hospital, Gothenburg0 个研究点目标入组 30 人开始时间: 2017年5月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males and females at ages 20-65 years
- •Previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency due to autoimmune adrenalitis, i.e. Addison´s disease
- •A stable daily glucocorticoid replacement dose for at least 3 months prior to study entry
- •An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose
- •If needed, a stable fludrocortisone replacement dose for at least 3 months prior to study entry
- •Body mass index (BMI) of 20-35 kg/m2
- •Ability to comply to the protocol procedures and having signed informed consent to participate in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepaticobiliary/ pancreatic disease which in the investigators judgement may interfere with the study assessment of completion of the study
- •Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L
- •Pregnant or lactating women
- •Diabetes Mellitus
- •Systemic infections
- •Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
- •Any medication with agents which in the investigators judgement might interfere with the study drugs kinetics, including therapies affecting gastro intestinal emptying or motility
- •Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator
- •Hypersensitivity to the active substance or any excipients used in the study drug of choice
- •Any additional underlying disease that may need regular or periodic pharmacological treatment with glucocorticoids during the trail, such as asthma, skin- or eye conditions treated with inhaled or topical glucocorticoids
- •Any additional underlying condition that needs treatment with intramuscular or intra-articular steroid injections during the trial
研究者
相似试验
进行中（未招募）
1 期
A Pilot Study of the Effect of Glucocorticoid Receptor Antagonism in Patients with Sub-Clinical Cushing's Syndrome - Glucocorticoid Receptor Antagonism in Sub-Clinical CushingsEUCTR2007-007604-15-GBSheffield Teaching Hospitals NHS Foundation Trust
招募中
4 期
Influence of glucocorticoids on sugammadex actioResidual neuromuscular blockadeAnaesthesiology - AnaestheticsACTRN12612000245897niversity Medical Center Ljubljana60
招募中
2 期
Impact of short-term low dose glucocorticoids on protein metabolismHealthy volunteersMetabolic and Endocrine - Normal metabolism and endocrine development and functionACTRN12605000443695St Vincent's Hospital8
进行中（未招募）
1 期
A study to assess whether a product call relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Endogenous Cushing syndromeMedDRA version: 20.0 Level: LLT Classification code 10011657 Term: Cushings syndrome System Organ Class: 100000004860EUCTR2018-003096-35-ESCorcept Therapeutics Incorporated130
进行中（未招募）
1 期
A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.EUCTR2018-003096-35-DECorcept Therapeutics Incorporated145