EUCTR2017-003932-35-BE进行中（未招募）1 期
Safety and Efficacy of BIO-101 175 mg b.i.d. and 350 mg b.i.d. 26-week oral administration to patients suffering from age-related SARcopenia, including sarcopenic obesity, Aged =65 years and at risk of mobility disability. A double-blind, placebo controlled, randomized INTerventional Clinical Trial (SARA-INT)
Biophytis S.A.0 个研究点目标入组 231 人开始时间: 2017年10月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 231
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
- •1. Provision of signed and dated informed consent form (ICF)
- •2. Stated willingness to comply with all study procedures and
- •availability for the duration of the study
- •3. Male or female aged = 65 years, living in the community
- •(living at home, able to walk outside from time to time. Homes
- •can include any living community that may or may not offer
- •optional services for the convenience of the residents. Older
- •adults living in nursing homes or in medicalized residences
- •where caretaker services are mandatory are not eligible) and
- •reporting a loss of physical function over the last 6-12
- •4. SPPB score = 8
- •5. ALM/BMI < 0.789 in men and <0.512 in women, or ALM <
- •19.75kg in men and < 15.02kg in women, as measured by
- •6. Ability to take oral medication and be willing to adhere to the
- •study intervention regimen (see section 6)
- •7. Agreement to adhere to the outlined Lifestyle Considerations
- •(see section 5.4) throughout the study duration
- •8. In the US, women and members of minority groups should not
- •be excluded, in accordance with the NIH Policy on Inclusion of
- •Women and Minorities as Participants In Research Involving
- •Human Subjects.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 231
排除标准
- •1. Current use of anabolic drugs (e.g. testosterone); current use
- •of Erythropoietin; current use of corticosteroid agents (except ocal administration route, like eye drops or dermatologic formulations)
- •2. Non-menopaused women (however, ongoing hormonal
- •replacement hormonal treatment is not an exclusion criterion)
- •3. Known allergic reactions to sourcing components of the investigational drug (i.e. Cyanotis species; e.g. Cyanotis arachnoidea C.B. Clarke or Cyanotis vaga Lour. (Shultes)
- •leaves and roots)
- •4. Treatment with another investigational drug or other interventions within three months
- •5. Unable to understand and perform the functional tests, as judged by the Investigator
- •6. Inability to perform the 400MW test within 15 minutes
- •7. Clinical conditions:
- •a. Current diagnosis of major psychiatric disorders.
- •b. Alcohol abuse or dependence
- •c. Severe arthritis
- •d. Cancer requiring active treatment (cancer previously
- •treated with chemotherapy and/or radiotherapy and
- •participants currently on remission is not an exclusion
- •e. Lung disease requiring regular use of supplemental
- •f. Inflammatory conditions requiring regular use of oral
- •or parenteral corticosteroid agents
- •g. Severe cardiovascular disease (including New York
- •Heart Association [NYHA] class III or IV congestive
- •heart failure, clinically significant valvular disease,
- •history of cardiac arrest, presence of an implantable
- •defibrillator, or uncontrolled angina)
- •h. Parkinson’s disease or other progressive neurological
- •i. Renal disease requiring dialysis, or known renal
- •insufficiency (moderate or severe reduction of
- •eGFR=30 ml/min/1.73 m2, based on Cockroft & Gault
- •j. Chest pain, severe shortness of breath, or occurrence
- •of other safety concerns during the baseline
- •functional tests such as the 400MW test
- •k. History or active signs or symptoms of
- •gallbladder/biliary disease (e.g. previous episodes of
- •cholestasis/biliary tract obstruction, cholelithiasis,
- •cholecystitis, etc.). Of note, history of
- •cholecystectomy and no active biliary signs or
- •symptoms, is not an exclusion criterion.
- •8. Current physical/rehabilitation therapy (except for passive
- •physical therapy. However, this should not be initiated the
- •week before an evaluation visit and once started, it should be
- •maintained over the study duration).
研究者
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