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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00671190 |
This was a Dose-Ranging Study to Evaluate TAK-375 at 1 mg, 2 mg, 4 mg, or 8 mg versus a placebo taken once daily for five days.
Condition | Intervention | Phase |
Sleep Disorder |
Drug: TAK-375 Drug: Placebo |
Phase II |
MedlinePlus related topics: | Sleep Disorders |
ChemIDplus related topics: | Ramelteon |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study to Evaluate the Phase-Shifting Effects of Repeated Daily Dosing of TAK-375 in Healthy Subjects |
Enrollment: | 75 |
Study Start Date: | March 2005 |
Study Completion Date: | May 2005 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1.: Experimental
TAK-375 1 mg tablet
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Drug: TAK-375
TAK-375 1 mg tablet, orally, taken once daily for five days
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2.: Experimental
TAK-375 2 mg tablet
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Drug: TAK-375
TAK-375 2mg tablet, orally, taken once daily for five days
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3.: Experimental
TAK-375 4 mg tablet
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Drug: TAK-375
TAK-375 4 mg tablet orally, taken once daily for five days
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4.: Experimental
TAK-375 8 mg tablet
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Drug: TAK-375
TAK-375 8 mg tablet, orally, taken once daily for five days
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5.: Placebo Comparator
Placebo tablet
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Drug: Placebo
placebo tablet orally, taken once daily for five days
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Eligible subjects were randomized to one of 5 treatments: TAK-375 1, 2, 4, or 8 mg, or placebo taken once daily, and were confined to the sleep laboratory for the Treatment Period (Day 1 to Day 5), where they received their assigned study medication and went to bed 5 hours earlier than their habitual bedtime—undergoing an 8-hour, PSG-recorded sleep each night. Upon awakening, subjects provided a salivary melatonin sample (within 5 minutes), and filled out a post-sleep questionnaire. Melatonin samples were collected every hour for 10 hours after awakening. On Day 5, subjects underwent end-of-study procedures and were discharged from the sleep laboratory.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |||||
Hot Springs, Arkansas, United States | |||||
United States, California | |||||
San Diego, California, United States | |||||
Los Angeles, California, United States | |||||
United States, Florida | |||||
Miami, Florida, United States | |||||
United States, Georgia | |||||
Atlanta, Georgia, United States | |||||
Macon, Georgia, United States | |||||
United States, Indiana | |||||
Danville, Indiana, United States | |||||
United States, Kansas | |||||
Overland Park, Kansas, United States | |||||
United States, Louisiana | |||||
Metairie, Louisiana, United States | |||||
United States, Maryland | |||||
Chevy Chase, Maryland, United States | |||||
United States, Nevada | |||||
Las Vegas, Nevada, United States | |||||
United States, Ohio | |||||
Dublin, Ohio, United States | |||||
United States, South Carolina | |||||
Columbia, South Carolina, United States |
Takeda Global Research & Development Center, Inc. |
Study Director: | Stephen Sainati, MD, PhD | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( VP, Clinical Science ) |
Study ID Numbers: | 01-02-TL-375-018 |
First Received: | May 1, 2008 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00671190 |
Health Authority: | United States: Food and Drug Administration |
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