Status:
COMPLETED
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Insomnia
Eligibility:
All Genders
20-84 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.
Detailed Description
This is a multicenter, randomized, double-blinded study to evaluate the long-term safety of SEP-190 (2, 3 mg) in non-elderly patients with insomnia and SEP-190 (1, 2 mg) in elderly patients with insom...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participants who submit written informed consent for study entry.
- Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.
- Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version or diagnosed with insomnia associated with psychiatric or physical disorder(s).
- Participants with both of the following conditions which are persistent for 4 weeks or longer before the start of observation period:
- Total sleep time is less than or equal to 390 minutes for more than or equal to 3 days a week
- Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week
- Participants with data at least 2 consecutive days in diary entries during observation period and confirmed to meet the following two criteria:
- Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
- Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week
- Exclusion criteria:
- Participants with a present or history of the following disease specified in
- Mini-International Neuropsychiatric Interview (M.I.N.I.) Japanese version 5.0:
- Risk of suicide
- (Mild) manic episode
- Post-traumatic stress disorder (PTSD)
- Alcohol dependence and abuse
- Drug (non-alcohol) dependence and abuse
- Anorexia nervosa
- Bulimia nervosa
- Anti-social personality disorder
- Participants with pharmacologically induced insomnia (drug-induced insomnia).
- Participants with comorbid primary sleep disorders (circadian rhythm disorder, restless legs movement syndrome, periodic limb movement disorder, sleep apnea syndrome, etc.) other than primary insomnia.
- Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough.
- Participants with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.
- Participants with organic mental disorder.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT00770692
Start Date
October 1 2008
End Date
May 1 2010
Last Update
November 22 2012
Active Locations (34)
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1
Nagoya, Aichi-ken, Japan
2
Akita, Akita, Japan
3
Fukuoka, Fukuoka, Japan
4
Iizuka, Fukuoka, Japan