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

NCT02087722 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-03-14

No results posted yet for this study

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.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

DRUG

KI1001

DRUG

Placebo

Sponsors & Collaborators

  • Neurim Pharmaceuticals Ltd.

    collaborator INDUSTRY

  • Kuhnil Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Seung-Chul Hong, M.D., Ph.D. · The Catholic University of Korea, St. Vincent Hospital

  • Doo-Heum Park, M.D., Ph.D. · Konkuk University Medical Center

  • Won-Chul Shin, M.D., Ph.D. · Kyung Hee University Hospital at Gangdong

  • Kyu-In Jung, M.D.,Ph.D. · Catholic University of Korea Saint Paul's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02087722 on ClinicalTrials.gov