A multicentric, randomized, comparative clinical trial of Armodafinil versus Modafinil in patients with excessive sleepiness associated with shift work sleep disorder (SWSD).

Emcure Pharmaceuticals Ltd Pune.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1)Male, non-pregnant female and female taking suitable precautions for contraception between the ages of 18 and 60 years worked each month at least five night shifts for 12 hours or less, with 6 hours or more worked between 10 p.m. and 8 a.m. and at least three shifts occurring consecutively.
•2)Patients with Shift work sleep disorder diagnosed by following (The international classification of sleep disorder) criteria:
•A.The patient has a primary complaint of insomnia or excessive sleepiness.
•B.The primary complaint is temporally associated with a work period (usually night work) that occurs during the habitual sleep phase.
•C.No medical or mental disorder accounts for the symptoms.
•D.The symptoms do not meet criteria for any other sleep disorder producing insomnia or excessive sleepiness (e.g., time-zone change [jet lag] syndrome).
•Minimal Criteria: A plus B.
•3)Willing to give written informed consent & willing to comply with trial protocol

•1)Patients < 18 and > 60 years of age.
•2)Patients with significant liver/kidney/heart diseases.
•3)Presence of clinically significant, uncontrolled psychiatric or medical condition.
•4)Patients with known history of hypersensitivity to formulation.
•5)Patients operating an automobile or hazardous machinery.
•6)Pregnant and lactating mother.
•7)Female of reproductive age and willing to become pregnant.
•8)Female of reproductive age using steroidal contraceptives.
•9)Patients with Alcohol or drug abuse.
•10)Caffeine consumption averaging more than 600 mg/day within 1 week of baseline
•11)Use of other concomitant medications which inhibit, induce or metabolized by CYP450 viz: Carbamazepine, phenobarbital, rifampin, ketoconazole, erythromycin, cyclosporine, ethinyl estradiol, triazolam, phenytoin, diazepam, and propranolol, omeprazole and clomipramine etc.
•12)Patients using sedative or CNS acting drugs or medication liable to affect outcome of the study (e.g. antihistamines, selective serotonin reuptake inhibitors, tricyclic antidepressants, lithium, antipsychotics, anticonvulsants, monoamine oxidase inhibitor, benzodiazepines, psychostimulants and anticoagulants).
•13)Patients without the ability to comply with the study protocol and complete the study in the judgment of the investigator.

发起方

Emcure Pharmaceuticals Ltd Pune.