2023-508169-34-00撤回3 期
Efficacy and safety of Escholzia tablets in adults with insomnia: a biphasic study with a randomized, placebo-controlled, double-blind, 1-month interventional, clinical trial phase (A) and a subsequent prospective, 1-armed, 2-months interventional trial phase (B).
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- A.Vogel AG
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Phase (A): Change in perceived sleep quality as measured with the Insomnia Severity Index (ISI)
研究概览
简要总结
The main objective of this study is to show efficacy on perceived sleep quality and safety profile of the newly developed pharmaceutical product Escholzia tablets for the treatment of insomnia according to the ICD-10 F51.0 diagnosis.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Voluntary, written, informed consent to participate in the study.
- •Male or female aged between 18-65 years (inclusive).
- •Diagnosis of insomnia according to ICD-10 F51.
- •ISI total score >
- •Habitual bedtime between 9 pm and midnight.
- •Easy access to internet for daily e-diary.
- •Freezing capacities available for storage of saliva samples.
排除标准
- •Body mass index (BMI) <18.0 or >30.0 kg/m
- •Have learning and/or behavioral difficulties such as dyslexia or attention deficit hyperactivity disorder (ADHD).
- •Have a visual impairment that cannot be corrected with glasses or contact lenses (including color-blindness).
- •History or planned travel to a different time zone within 1 month of the first visit or/and during the study participation.
- •Shift-workers.
- •Not fluent in German.
- •Have (known) hypersensitivity to plants from the poppy family (Papaveraceae) or known hypersensitivity to the active substance/s (Eschscholzia californica, microcrystalline cellulose, Colloidal anhydrous silica, sodium croscarmellose, glycerol distearate, caramel couleur and Ferrous(III) oxide ).
- •Participation in another study with any investigational product within 30 days of screening and during the intervention period.
- •Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
- •Individual is pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- •Any known acute history of a disorder affecting sleep quality, such as narcolepsy, obstructive sleep apnea (OSA), restless leg syndrome (RLS), periodic limb movement syndrome (PLMS) or any organic caused sleep disorders e.g. benign prostatic hyperplasia (BPH), urinary tract infections, irritated bladder
- •Any known acute history of psychiatric illness (e.g., mono- or bipolar depression, anxiety disorders, personality disorders, borderline personality disorder, psychoses).
- •Have a significant acute or chronic coexisting illness or any condition which contraindicates entry to the study in the opinion of the Investigator (e.g. migraines, active infections, renal insufficiency, hepatopathy, dementia).
- •Current or recent (within past 4 weeks) intake of drugs that could influence sleep (e.g., psychotropic, sedatives, hypnotics, nicotine-replacement therapies, over-the-counter sleep aids, hormone therapy, health products and oriental herbs (such as valerian, hops, passionflower, hypericum, etc.).
- •Current or recent (within 1 year) alcohol abuse, heavy smoking (>10 cigarettes/day), high caffeine intake (>10 glasses/day).
- •Self-declared regular illicit drug use (including cannabis and cocaine).
- •Have a high blood pressure (systolic over 159 mmHg or diastolic over 99 mmHg).
结局指标
主要结局
Phase (A): Change in perceived sleep quality as measured with the Insomnia Severity Index (ISI)
Phase (A): Change in perceived sleep quality as measured with the Insomnia Severity Index (ISI)
Phase (B): Safety and tolerability of treatment according to safety assessment
Phase (B): Safety and tolerability of treatment according to safety assessment
次要结局
- Change in perceived sleep quantity/quality as per the daily sleep diary
- Change in physiological sleep quantity as measured via actigraphy (wearable)
- Change in daytime sleepiness as measured with the Epworth-Sleepiness-Scale (ESS)
- Change in state anxiety as measured with the State-Trait-Anxiety-Inventory (STAI-X1)
- Change in mood as measured with the Depression, Anxiety, Stress Scale (DASS-21)
- Change in general quality of life as measured with the World Health Organization Quality of Life inventory (WHOQOL)-BREF
- Change in happiness and satisfaction via the Oxford Happiness Questionnaire (OHQ)
- Domain specific cognitive performance as measured via the Computerized Mental Performance Assessment System (COMPASS)
- Change in biomarker for stress via the salivary evening cortisol level (8 pm)
- Change in biomarker for sleep readiness via the salivary evening melatonin level (8 pm)
- Change in biomarker for chronic stress via the CAR determined as area under the curve (AUC) and increase
- Change in pain intensities
- Change in sleep quantity as measured via PSG device
研究者
Roland Schoop, PhD
Scientific
A.Vogel AG
研究点 (1)
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