A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia
Information source: Eisai Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia
Intervention: eszopiclone (Drug); eszopiclone (Drug); eszopiclone (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Eisai Inc. Official(s) and/or principal investigator(s):
Atsushi Kamijo, Study Director, Affiliation: New Product Development Department, Clinical Research Center
Overall contact:
Customer Information Services Department. CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp
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.
Clinical Details
Official title: A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety Study
Primary outcome: Adverse events.
Secondary outcome: Adverse drug reactions, blood pressure, pulse rate, laboratory evaluations, electrocardiogram (ECG) measurements, questionnaire of drug dependence.Sleep diary questionnaire Sleep questionnaire, Pittsburgh sleep quality index Japanese version (PSQI), Short Form-36 Health Survey version 2-Japanese version (SF-36).
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 insomnia.
Eligibility
Minimum age: 20 Years.
Maximum age: 84 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
1. Patients who submit written informed consent for study entry.
2. Patients aged greater than or equal to 20 and less than 85 years of age at the time
of obtaining informed consent.
3. Patients 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).
4. Patients 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
5. Patients 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:
1. Patients with a present or history of the following disease specified in
Mini-International Neuropsychiatric Interview (M. I.N. I.) Japanese version 5. 0.0:
- 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
2. Patients with pharmacologically induced insomnia (drug-induced insomnia).
3. Patients with comorbid primary sleep disorders (circadian rhythm disorder, restless
legs movement syndrome, periodic limb movement disorder, sleep apnea syndrome, etc.)
other than primary insomnia.
4. Patients with symptoms significantly disturb sleep such as pain, fever, diarrhea,
frequent macturition, and cough.
5. Patients with unstable primary disease presenting insomnia during 4 weeks before the
start of observation period.
6. Patients with organic mental disorder.
Locations and Contacts
Customer Information Services Department. CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp
Akita, Japan; Recruiting
Fukuoka, Japan; Recruiting
Kochi, Japan; Recruiting
Kumamoto, Japan; Recruiting
Kyoto, Japan; Recruiting
Osaka, Japan; Recruiting
Nagoya, Aichi, Japan; Recruiting
Kurume, Fukuoka, Japan; Recruiting
Iizuka, Fukuoka, Japan; Recruiting
Onga, Fukuoka, Japan; Recruiting
Kitakyushu, Fukuoka, Japan; Recruiting
Maebashi, Gunma, Japan; Recruiting
Sapporo, Hokkaido, Japan; Recruiting
Itami, Hyogo, Japan; Recruiting
Yokohama, Kanagawa, Japan; Recruiting
Kashiba, Nara, Japan; Recruiting
Urazoe, Okinawa, Japan; Recruiting
Kishiwada, Osaka, Japan; Recruiting
Ibaragi, Osaka, Japan; Recruiting
Fujimi, Saitama, Japan; Recruiting
Kusatsu, Shiga, Japan; Recruiting
Chuo-ku, Tokyo, Japan; Recruiting
Ota-ku, Tokyo, Japan; Recruiting
Arakawa-ku, Tokyo, Japan; Recruiting
Koto-ku, Tokyo, Japan; Recruiting
Shinjuku-ku, Tokyo, Japan; Recruiting
Edogawa-ku, Tokyo, Japan; Recruiting
Shinagawa-ku, Tokyo, Japan; Recruiting
Toshima-ku, Tokyo, Japan; Recruiting
Minato-ku, Tokyo, Japan; Recruiting
Kodaira, Tokyo, Japan; Recruiting
Musashino, Tokyo, Japan; Recruiting
Sagamihara, Yokohama, Japan; Recruiting
Additional Information
Starting date: October 2008
Last updated: August 26, 2009
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