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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: | NCT00671125 |
The purpose of this study is to determine the safety and efficacy of TAK-375 in the treatment of chronic insomnia using polysomnography and subjective measures of sleep
Condition | Intervention | Phase |
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Chronic Insomnia |
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 Phase III, Randomized, Double-Blind Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of TAK-375 in Adults With Chronic Insomnia |
Enrollment: | 405 |
Study Start Date: | January 2003 |
Study Completion Date: | September 2003 |
Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1.: Experimental |
Drug: TAK-375
TAK-375 8 mg, tablets, orally, once nightly for up to 5 weeks.
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2.: Experimental |
Drug: TAK-375
TAK-375 16 mg, tablets, orally, once nightly for up to 5 weeks.
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3.: Placebo Comparator |
Drug: Placebo
TAK-375 placebo-matching tablets, orally, once nightly for up to 5 weeks.
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Insomnia is characterized by difficulties initiating and maintaining sleep or of nonrestorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.
TAK-375 is a selective melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
This study will determine the safety and efficacy of 35-day treatment of chronic insomnia with TAK-375 using polysomnography and subjective measures of sleep. Participation in this study is anticipated to be about 2 months.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Any additional condition(s) that in the Investigator's opinion would:
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
Study Director: | VP Clinical Science | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | 01-02-TL-375-021 |
Study First Received: | May 1, 2008 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00671125 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sleep Disorder Insomnia Drug Therapy |
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 |