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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: | NCT00568789 |
This is a crossover study of ramelteon 8 mg and zolpidem 10 mg compared with placebo in elderly patients with primary insomnia. Each subject is to receive a treatment sequence of all three treatments, randomized to different order; each treatment is for 1 day, with a washout period between each treatment. This study is designed to investigate the effects of ramelteon on balance, mobility, and memory impairment after middle-of-the-night awakening following bedtime dosing.
Condition | Intervention | Phase |
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Insomnia |
Drug: ramelteon Drug: zolpidem Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Study of the Safety of Ramelteon in Elderly Subjects |
Enrollment: | 33 |
Study Start Date: | June 2006 |
Study Completion Date: | September 2006 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ramelteon
8 mg ramelteon tablet, orally, one night only
Drug: zolpidem
10 mg zolpidem tablet, orally, one night only
Drug: placebo
Placebo tablet, orally, one night only
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Subjects participating in this study will be randomized to receive in different order a single dose of 8 mg of ramelteon, 10 mg of zolpidem and a placebo over three overnight stays at a research facility. The 3 treatment days are each separated by a 5 to 10 days.
Subjects will be given their assigned treatment as a single dose on the night of treatment, awakened 2 hours after dosing, and tested for mobility, balance, immediate memory recall, and delayed memory recall. Safety is to be measured through the record of adverse events, vital sign measurements, clinical laboratory tests, and electrocardiogram tracing.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Costa Mesa, California, United States | |
San Diego, California, United States | |
United States, Florida | |
Miami, Florida, United States | |
Miramar, Florida, United States | |
Orlando, Florida, United States | |
United States, New York | |
New York, New York, United States |
Study Director: | Sherry Weigand, MD, PhD | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( VP, Clinical Science ) |
Study ID Numbers: | 01-05-TL-375-060 |
Study First Received: | December 4, 2007 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00568789 |
Health Authority: | United States: Food and Drug Administration |
Insomnia Aged Postural Balance Drug Therapy |
Zolpidem |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses GABA Agonists Hypnotics and Sedatives |
Physiological Effects of Drugs Central Nervous System Depressants GABA Agents Central Nervous System Agents Pharmacologic Actions |