Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia
|ClinicalTrials.gov Identifier: NCT00671255|
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : February 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Insomnia||Drug: Ramelteon Drug: Placebo||Phase 3|
Insomnia is characterized by a complaint of initiating and maintaining sleep or complaints 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.
Ramelteon is a selective melatonin-1 receptor agonist under development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
Ramelteon is the first candidate in a novel class of drugs based on this mechanism. Based on non-clinical and clinical studies completed to date, TAK-375 has the potential to offer unique advantages relative to approved hypnotics in terms of its pharmacological profile and its selectivity to the melatonin-1 receptor.
This study is designed to determine the safety and efficacy of 35-day treatment of chronic insomnia with ramelteon. Participation in this study is anticipated to be approximately 2 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||829 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Elderly Subjects With Chronic Insomnia|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||January 2004|
|Experimental: Ramelteon 4 mg QD||
Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.
|Experimental: Ramelteon 8 mg QD||
Ramelteon 8 mg, tablets, orally, once daily for up to 5 weeks.
|Placebo Comparator: Placebo||
Ramelteon placebo-matching, tablets, orally, each night for up to 35 consecutive days.
- Mean Subjective Sleep Latency per subject diary, from Nights 1 through 7 of double-blind Treatment [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
- Subjective Total Sleep Time. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
- Subjective Number of Awakenings. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
- Subjective Ease of Falling Back to Sleep after Awakening. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
- Subjective Sleep Quality. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
- Clinical Global Impression Change of Condition. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
- Clinical Global Impression Severity of Illness. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
- Clinical Global Impression Therapeutic Effect. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
- Clinical Global Impression Side Effects. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
- Average Subjective Sleep Latency over the week preceding the Day 15, Day 22, Day 29, and Day 36 Visits. [ Time Frame: Weeks 2, 3, 4 and 5 or Final Visit. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671255
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|Study Director:||VP Clinical Science||Takeda|