CTRI/2010/091/001443已完成3 期
A Double Blind, Randomized, Parallel Group, Prospective, Multicentre Clinical Trial for Evaluation of Efficacy and Safety of IN-AQUL-001 in Comparison with Zopiclone in Adult and Elderly Patients with Primary Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients with:
- •1)Either sex 18 to 75 years of age
- •2)Primary insomnia as defined by the DSM-IV for at least 1 month.
- •3)Mean subjective 1) LSO ≥ 20 minutes; 2) WASO ≥ 60 minutes; 3) TST ≤ 390 minutes, based on sleep diary recorded during placebo run-in period
- •4)Female patients of childbearing potential: nonpregnant, nonlactating, with negative serum pregnancy test at screening and willing to utilize an acceptable method of contraception throughout the study period.
- •5)Willing to provide written informed consent
排除标准
- •Patients with:
- •1)Disease associated:
- •?History of sleep apnea syndrome
- •?Concomitant history of cognitive disorders, depression, schizophrenia, panic disorder, dementia, chronic pain, glaucoma, frequent nightly urination, significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, metabolic disorders
- •?History of suicidal tendency, fibromyalgia, seizures (excluding childhood febrile seizures), and chronic obstructive pulmonary disease.
- •2)Drug associated:
- •?Known hypersensitivity to any of study medications;
- •?Has participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of study medication
- •?Is required to take or intends to continue taking any disallowed medication or any prescription medication or over-the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication,
- •?Has used any central nervous system medication or other drugs or supplements known to affect sleep pattern within 1 week prior to the administration of double-blind study medication.
- •?History of drug induced leucopenia/neutropenia/agranulocytosis
- •3)Investigations associated:
- •?Serious hepatic disease (SGPT/OT≥2.5 times UNL)
- •?Cardiac arrhythmia, QT prolongation or conditions predisposing for prolongation of QT interval
- •?Hyperglycemia (Random blood sugar ≥ 140 mg/dL) or diabetes mellitus
- •?Has any other clinically important abnormal finding
- •4)Requirement of sleep schedule changes as a part of his professional duty.
- •5)History of substance abuse including tobacco, alcohol and caffeine
- •6)As deemed inappropriate for enrollment by investigating physician due to other reasons.
研究者
相似试验
进行中（未招募）
1 期
AN EQUIVALENCE TRIAL TO COMPARE THE EFFICACY, SAFETY, PHARMACOKINETICS AND IMMUNOGENICITY OF HD204 TO AVASTIN® IN PATIENTS WITH LUNG CANCER.EUCTR2017-005175-78-BGPrestige Biopharma Limited650
进行中（未招募）
1 期
AN EQUIVALENCE TRIAL TO COMPARE THE EFFICACY, SAFETY, PHARMACOKINETICS AND IMMUNOGENICITY OF HD204 TO AVASTIN® IN PATIENTS WITH LUNG CANCER.on-squamous Non-small Cell Lung Cancer (nsNSCLC)MedDRA version: 20.0Level: LLTClassification code 10079440Term: Non-squamous non-small cell lung cancerSystem Organ Class: 100000004864EUCTR2017-005175-78-LVPrestige BioPharma Limited592
进行中（未招募）
1 期
AN EQUIVALENCE TRIAL TO COMPARE THE EFFICACY, SAFETY, PHARMACOKINETICS AND IMMUNOGENICITY OF HD204 TO AVASTIN® IN PATIENTS WITH LUNG CANCER.EUCTR2017-005175-78-HUPrestige BioPharma Pte Ltd592
进行中（未招募）
1 期
AN EQUIVALENCE TRIAL TO COMPARE THE EFFICACY, SAFETY, PHARMACOKINETICS AND IMMUNOGENICITY OF HD204 TO AVASTIN® IN PATIENTS WITH LUNG CANCER.on-squamous Non-small Cell Lung Cancer (nsNSCLC)MedDRA version: 20.0Level: LLTClassification code 10079440Term: Non-squamous non-small cell lung cancerSystem Organ Class: 100000004864EUCTR2017-005175-78-PLPrestige BioPharma Limited592
招募中
3 期
A Phase III Trial to Compare the Effectiveness, Safety and action of HD204 (study drug) in comparison to Avastin�® in patients with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (cancer of the lungs)CTRI/2019/09/021090Prestige BioPharma Limited