A Prospective, Multicenter, Open labeled, Randomized, phase IV clinical study to evaluate safety and efficacy of 2 FDCs of Zolpidem Tartrate IP 5 mg / 10 mg plus Melatonin 3 mg film coated tablets in subjects with Primary Insomnia and Sleep Disorder.
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 220
- Locations
- 4
- Primary Endpoint
- To evaluate the safety and tolerability of 2 FDCs of Zolpidem Tartrate IP 5 mg and Melatonin 3 mg with Zolpidem Tartrate IP 10 mg and Melatonin 3 mg film coated tablets in subjects with Primary Insomnia & Sleep Disorder.
Study Overview
Brief Summary
This phase IV clinical trial is a prospective, multicenter, open-label, randomized study aimed at evaluating the safety and efficacy of two fixed-dose combinations (FDCs) in treating subjects with primary insomnia and sleep disorders. Spanning 4 weeks more or less 2 Days, the trial will involve 220 male and female participants aged 18-65, selected based on specific inclusion and exclusion criteria across four sites. The primary objective is to assess the safety and tolerability of the FDCs, with endpoints including Clinical Global Impression-change, average sleep latency, and adverse events, evaluated at baseline, Day 14, and Day 28. The secondary objective focuses on the efficacy of the FDCs, measured by changes in the Insomnia Severity Index at the same time intervals. Participants are required to take one tablet orally each night for 28 days. The trial procedure involves an initial baseline visit for informed consent, demographic data collection, medical history review, and initial assessments, followed by subsequent visits at two-week intervals for ongoing evaluations, diary reviews, and compliance checks. Emphasis is placed on contraception for female participants and rigorous monitoring to ensure the integrity of the study and the safety of the subjects throughout the trial.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Signed informed consent prior to any study mandated procedure.
- •Women of childbearing potential must have negative pregnancy tests and use reliable methods of contraception up to 30 days after EOT.
- •Body mass index between 18.5 to 32.0 kg per m
- •Insomnia disorder according to DSM 5 criteria.
- •Insomnia Severity Index score equal or grater than 15.
Exclusion Criteria
- •Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement behavior disorder, or narcolepsy.
- •Self-reported usual daytime napping greater than equal to 1 hour per day, and greater than equal to 3 days per week.
- •Caffeine consumption greater than equal to 600 mg per day.
- •Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
- •Travel greater than equal to 3 time zones within 1 week prior to the screening visit, or planned travel greater than equal to 3 time zones during study.
- •Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
- •Except for the known history of Gilberts syndrome.
- •Severe renal impairment Which is known or defined as estimated creatinine clearance less than 30 mL per min).
- •History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject full participation in the study or compliance with the protocol.
Outcomes
Primary Outcomes
To evaluate the safety and tolerability of 2 FDCs of Zolpidem Tartrate IP 5 mg and Melatonin 3 mg with Zolpidem Tartrate IP 10 mg and Melatonin 3 mg film coated tablets in subjects with Primary Insomnia & Sleep Disorder.
Time Frame: Day1, Day 14, Day 28
Secondary Outcomes
- To evaluate efficacy of 2 FDCs of Zolpidem Tartrate IP 5 mg and Melatonin 3 mg with Zolpidem Tartrate IP 10 mg and Melatonin 3 mg film coated tablets in subjects with Primary Insomnia & Sleep Disorder.(Day 1, Day 14, Day 28)
Investigators
Dr Vipul Mishra
Pushpanjali Hospital and Research center