NCT02087722

Efficacy and Safety of KI1001 in the Treatment of ≥ 55 Years Old Insomnia Patients

A Double-blind, Parallel Group, Randomised, Placebo Controlled, Multicenter, Bridging Study of Efficacy and Safety of KI1001 in the Improvement of Sleep Quality in ≥ 55 Years Old Insomnia Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Kuhnil Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy to improve sleep quality in over 55 years old primary insomnia patients. This is a 2nd bridging study to investigate the efficacy and safety of KI1001(Circadin®) in Korean patients.

Detailed description

This study is conducted using a randomised, double-blind, placebo controlled parallel group design, after a single-blind placebo period. Primary insomnia patients aged over 55 will be screened for entry into the study. After placebo run-in period, Patients will enter a 3 weeks double-blind treatment period. Primary parameter is quality of sleep, secondary parameters are including getting to sleep, awakening from sleep, behavior following wakefulness, quality of day and night, sleep latency and quality of life.

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
DRUG	KI1001
DRUG	Placebo

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2014-03-14
• Last updated: 2014-03-14

Locations

4 sites across 1 country: South Korea