CTRI/2026/02/102974尚未招募3 期
A Prospective, Multicenter, Randomized, Assessor blind, Parallel-group, Active-Controlled, Phase III Comparative Study to Evaluate the Efficacy and Safety of Suvorexant Tablets in Comparison to Lemborexant Tablets in Patients with Insomnia
Sun Pharmaceutical Industries Limited (SPIL)23 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2026年2月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 410
- 试验地点
- 23
研究概览
简要总结
This Phase III, randomized, assessor-blind, multi-center study aims to compare the safety and efficacy of Suvorexant Tablets to Lemborexant Tablets in patients diagnosed with Insomnia. The trial will be conducted across 20 to 30 qualified centres in India and will begin only after receiving regulatory and ethics committee approvals.
A total of 410 patients will approximately be enrolled in the trial. After confirming eligibility, patients will be randomized in 1:1 ratio to either Test arm or Comparator arm (205 patients in Test arm and 205 patients in Comparator arm). Patients will receive the study drugs till week 12.
Patients will be provided a sleep diary wherein patients will record sleep related information (latency to sleep, total sleep time, wakefulness after sleep, number of awakening during the night) along with adverse events and concomitant medications if any. The primary end point of the study is to assess change from baseline in latency to sleep onset at Week 12. Safety assessments will include recording of AEs, TEAEs, serious adverse events (SAEs), vital signs [pulse rate, systolic and diastolic blood pressure (seated), body temperature and respiratory rate], ECG, physical examination, clinical laboratory investigations (hematology, biochemistry and urinalysis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female, aged 18 to 65 years (both inclusive) at the time of informed consent
- •Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia Disorder
- •Patients should have time to sleep onset greater than or equal to 30 minutes and total sleep time of less than 6.5 hours on at least 4 out of 7 nights in last 4 weeks before screening
- •Insomnia severity index score greater than or equal to 15 at Screening and randomization visit
- •Women of childbearing potential must have a negative urine pregnancy test at screening visit and randomization visit and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study (such contraception may include hormonal birth control e.g. combined oestrogen and progestogen containing [oral, intravaginal or transdermal] or progesterone only [oral, injectable or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence).
- •[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal.
- •Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhoea and be greater than 45 years of age].
- •Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners should be practicing highly effective contraception throughout the study period.
- •Contraception by female partner is not required if she is not a woman of childbearing potential) [No sperm donation is allowed during the study period].
排除标准
- •Patient will be excluded if any of the exclusion criteria listed below is met:
- •Patients with Body Mass Index (BMI) greater than 40 kg/m2
- •Patients with history of sleep related breathing disorders such as obstructive sleep apnea, central sleep apnea periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, narcolepsy, cataplexy, parasomnia including nightmare disorder, sleep terror disorder, sleep walking disorder, sleep driving disorder, primary hypersomnia, excessive daytime sleepiness disorder not attributable to primary insomina, periodic limb movement disorder
- •Patient who have difficulty sleeping due to underlying medical condition such as but not limited to cardiac disease, nocturia (greater than 3 times/night), asthma, gastroesophageal reflux disease (GERD), hot flashes, pain due to chronic conditions, migraine etc
- •Patients with major travel (across time zones) in 2 weeks prior to screening or expected to travel during the study
- •Patients with history of working in shifts and/or working in night shifts in 2 weeks prior to screening or will be required to work in a shift and/or night shift during the study.
- •Patients with neurological disorder, such as but not limited to seizures, stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or clinically significant head trauma
- •Patient who has history of any psychiatric condition such as bipolar disorder, major depression, posttraumatic stress disorder etc.
- •Patients with History of alcohol or substance dependency or abuse in last 2 years
- •Patients with positive result of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening visit
- •Patients with any significant cardiovascular abnormality including acute coronary syndrome, unstable angina, congestive heart failure (NYHA III or IV), cardiogenic syncope, cardiomyopathy, Any symptomatic arrythmia, AV conduction diseases (second- or third-degree AV block), sick sinus syndrome, bradycardia (heart rate at resting less than 45 at screening), or accessory bypass tract (for example, Wolff- Parkinson-White), QTcF greater than 450 ms) at screening.
- •Patients with history of any liver disorder of gastrointestinal disorder or gastrointestinal surgery including gastric bypass or gastric banding surgery.
- •Subject had a history of malignancy 5 years or more prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- •Patients who are not willing to avoid alcohol during the study
- •Prior use of orexin receptor antagonist and no adequate response to therapy
- •Hypersensitivity to the study drug or any of the excipients.
- •Patients with history of any clinically significant medical and/or psychological condition or laboratory abnormalities that, in the opinion of the Investigator or Sponsor’s Medical Monitor would jeopardize the safety of the patient or affect the validity of the study results
- •Patient with history of participation in another clinical trial in the past 3 months of Screening
- •Employee of the Sponsor or Investigator or study centre with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees of Sponsor or the Investigator.
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited
研究点 (23)
Loading locations...
相似试验
招募中
2/3 期
A clinical trial to assess Safety and Immunogenicity of SII yellow fever vaccine in AdultsYellow FeverCTRI/2024/03/063471Dr Prasad Kulkarni MD580
招募中
3 期
A clinical study to check efficacy and safety of Envafolimab injection in treatment of lung cancer.CTRI/2025/09/094871Glenmark Specialty SA180
招募中
4 期
A Study to Assess the Safety of Addaven in Adult Patients Needing Intravenous Nutrition After SurgeryCTRI/2025/07/091425Fresenius Kabi India Pvt. Ltd188
招募中
4 期
RWS of Tunlametinib in NRAS-Mutant Advanced MelanomaNCT07445022Fudan University110
尚未招募
2 期
Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid TumorsNCT07327411Second Affiliated Hospital of Soochow University40