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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00756002 |
The purpose of this study is to determine the safety and efficacy of 4 mg of TAK-375 in subjects with chronic insomnia.
Condition | Intervention | Phase |
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Sleep Initiation and Maintenance Disorders |
Drug: TAK-375 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Polysomnography Plus Outpatient Study to Determine the Safety and Efficacy of 4 mg Ramelteon in Adults With Chronic Insomnia |
Enrollment: | 259 |
Study Start Date: | August 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: TAK-375
TAK-375 4 mg, tablets, orally, once daily for up to 5 weeks.
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2: Placebo Comparator |
Drug: Placebo
TAK-375 placebo-matching tablets, orally, once daily for up to 5 weeks.
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Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Based on sleep history, the subject has had chronic insomnia for at least 3 months, as defined by the following:
Subjects must agree to discontinue the use of all sleep aids beginning 1 week prior to the first dose of single-blind study medication and throughout the entire duration of the study.
Exclusion Criteria:
The subject is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Exhibits a placebo response during the single-blind placebo run-in period. A placebo response is defined as having:
Has any additional condition(s) that in the Investigator's opinion would:
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr VP, Clinical Science ) |
Study ID Numbers: | 01-06-TL-375-081, 2007-000403-15 |
Study First Received: | September 17, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00756002 History of Changes |
Health Authority: | European Union: European Medicines Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices |
Chronic Insomnia DIMS (Disorders of Initiating and Maintaining Sleep) Disorders of Initiating and Maintaining Sleep Insomnia Disorder Sleep Initiation Dysfunction |
Transient Insomnia Drug Therapy Sleep Disorders, Intrinsic |
Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Sleep Initiation and Maintenance Disorders Mental Disorders Nervous System Diseases |
Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |