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

NCT01450228 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2012-04-24

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 bridging study to investigate the efficacy and safety of KI1001(Circadin®) in Korean patients.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

DRUG

KI1001

Prolonged release melatonin 2mg

DRUG

Placebo KI1001

Placebo KI1001 tablets

Sponsors & Collaborators

  • Neurim Pharmaceuticals Ltd.

    collaborator INDUSTRY

  • Kuhnil Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jin-Sang Yoon, M.D., Ph.D. · Chonnam National University Hospital

  • Jung-Hie Lee, M.D., Ph.D. · KangWon National University Hospital

  • 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

  • In-Young Yoon, M.D., Ph.D. · Seoul National University Bundang Hospital

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

  • Yong-Won Cho, M.D., Ph.D. · Keimyung University Dongsan Medical Center

  • Jee-Hyun Kim, M.D., Ph.D. · Dankook University

  • Seock-Hoon Chung, M.D., Ph.D. · University of Ulsan College of Medicine, Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • South Korea

Study Locations

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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 NCT01450228 on ClinicalTrials.gov