Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.

Sponsor

Takeda (Industry)

Overall Status

Completed

CT.gov ID

NCT00414102

Collaborator

(none)

552

Enrollment

Locations

Arms

Duration (Months)

10.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the subjective treatment effects of ramelteon, once daily (QD), on sleep using a post sleep questionnaire-interactive voice response system in adults with chronic insomnia.

Condition or Disease	Intervention/Treatment	Phase
Chronic Insomnia	Drug: Ramelteon Drug: Placebo	Phase 4

Detailed Description

Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related conditions that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.

Ramelteon is marketed for the treatment of insomnia characterized by difficulty with sleep onset under the brand name of Rozerem™.

This study will be comprised of two groups of subjects, 1) an outpatient group and 2) an inpatient group. The inpatient group will be used as reference arm as previously conducted studies in the sleep laboratory setting. Study participation is anticipated to be about 50 days (approximately 1.75 months).

Study Design

Study Type:

Interventional

Actual Enrollment :

552 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Demonstrate the Subjective Treatment Effects of Ramelteon on Sleep Using a Post Sleep Questionnaire - Interactive Voice Response System (PSQ-IVRS) in an "At-Home Setting" in an Adult Population With Chronic Insomnia

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ramelteon 8 mg QD	Drug: Ramelteon Ramelteon 8mg, tablets, orally, once nightly for up to 28 days. Other Names: TAK-375 Rozerem™
Placebo Comparator: Placebo QD	Drug: Placebo Ramelteon placebo-matching tablets, orally, once nightly for up to 28 days.

Arm

Intervention/Treatment

Experimental: Ramelteon 8 mg QD

Drug: Ramelteon

Ramelteon 8mg, tablets, orally, once nightly for up to 28 days.

Other Names:

TAK-375

Rozerem™

Placebo Comparator: Placebo QD

Drug: Placebo

Ramelteon placebo-matching tablets, orally, once nightly for up to 28 days.

Outcome Measures

Primary Outcome Measures

Average subjective Sleep Latency from Day 15 to Day 21 [Day 22]

Secondary Outcome Measures

Subjective Measures of Sleep Latency. [Weeks 1 and 2 or Final Visit]
Subjective Total Sleep Time. [Weeks 1, 2 and 3 or Final Visit]
Wake Time after Sleep Onset [Weeks 1, 2 and 3 or Final Visit]
Number of Awakenings. [Weeks 1, 2 and 3 or Final Visit]
Quality of Sleep. [Weeks 1, 2 and 3 or Final Visit]
Rebound insomnia assessed from Nights 22 to 28 via self-reported sleep latency. [Day 29]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Body mass index between 18 and 34, inclusive.
Based on sleep history, has had chronic insomnia for at least 3 months.
Based on sleep history, reports a history of subjective sleep latency greater than or equal to 60 min and a subjective total sleep time of less than or equal to 6.5 hours.
The difference of the average subjective sleep latency from days 1-3 to days 5-7 has to be less than or equal to 20 minutes during the single blind run-in period.
On at least 3 of the first 5 nights of single-blind run-in placebo treatment, the subject must have an subjective sleep latency of greater than or equal to 45 minutes and subjective total sleep time of less than or equal to 6.5 hours.
Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM.
Willing to have a fixed bedtime and agrees to go to bed within 30 minutes of the habitual bedtime during the entire study.
Consistent access to a touch-tone phone and are willing to complete all paper and telephone questionnaires within 60 minutes of awakening each morning throughout the entire duration of the study.
Willing to remain in bed for at least 6.5 hours each night during the entire study.
Based on sleep history, uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months.

Exclusion Criteria

Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.
Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.
Has sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication.
Has flown across greater than 3 time zones within 7 days prior to screening, or will travel across 2 or more time zones during the course of the study.
Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first night of single-blind study medication.
Has ever had a history of seizures; sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease, fibromyalgia, or a positive test result for the aforementioned ailments on the screening polysomnography.
History of psychiatric disorder within the past 6 months.
History of drug addiction or drug abuse within the past 12 months.
History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week, or for the inpatient subject consumed any alcoholic drinks within 24 hours of any polysomnography visits.
Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, neurological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication.
Uses tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle.
Positive urine drug screen at initial screening Visit 2.
For inpatient subjects: has a positive breathalyzer test on any of the PSG assessment visits.
Exhibit a placebo response during single blinded placebo run in period.
Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
Any additional condition(s) that in the Investigator's opinion would:
affect sleep/wake function
prohibit the subject from completing the study
indicate that continuation in the study would not be in the best interests of the subject.
Positive hepatitis panel including hepatitis A virus- Immunoglobulin M, hepatitis-B surface antigen, hepatitis C virus antibody.
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including the following:
Anxiolytics Antipsychotics
over-the-counter and Prescription Sedatives
Hypnotics
Narcotic analgesics
Antidepressants
Beta-blockers
Anticonvulsants
St. John's wort
Sedating H1 antihistamines
Kava-kava
Systemic steroids
Ginkgo-biloba
Respiratory stimulants
over-the-counter and prescription diet aids
Sedating Decongestants
Muscle relaxants
Melatonin and all other drugs or supplements known to affect sleep/wake function.

Contacts and Locations

Locations

	City	State	Country
1	Phoenix	Arizona	United States
2	Tucson	Arizona	United States
3	Hot Springs	Arkansas	United States
4	Los Angeles area	California	United States
5	San Diego	California	United States
6	Colorado Springs	Colorado	United States
7	Denver area	Colorado	United States
8	Delray Beach	Florida	United States
9	Ft. Myers	Florida	United States
10	Miami	Florida	United States
11	Naples	Florida	United States
12	Ocala	Florida	United States
13	Orlando	Florida	United States
14	Tampa	Florida	United States
15	Atlanta	Georgia	United States
16	Honolulu	Hawaii	United States
17	Boise	Idaho	United States
18	Chicago	Illinois	United States
19	Kansas City area	Kansas	United States
20	Lexington	Kentucky	United States
21	Baton Rouge	Louisiana	United States
22	Auburn	Maine	United States
23	Baltimore area	Maryland	United States
24	Washington D.C. area	Maryland	United States
25	Hattiesburg	Mississippi	United States
26	St. Louis area	Missouri	United States
27	Albuquerque	New Mexico	United States
28	Long Island	New York	United States
29	New York	New York	United States
30	Rochester	New York	United States
31	Staten Island	New York	United States
32	Charlotte	North Carolina	United States
33	Morganton	North Carolina	United States
34	Winston/Salem	North Carolina	United States
35	Akron	Ohio	United States
36	Cincinnati	Ohio	United States
37	Cleveland	Ohio	United States
38	Gallipolis	Ohio	United States
39	Oklahoma City	Oklahoma	United States
40	Portland area	Oregon	United States
41	Clarkes Summitt	Pennsylvania	United States
42	Philadelphia	Pennsylvania	United States
43	Pittsburgh	Pennsylvania	United States
44	Anderson	South Carolina	United States
45	Charleston area	South Carolina	United States
46	Austin	Texas	United States
47	Dallas	Texas	United States
48	Houston	Texas	United States
49	Norfolk	Virginia	United States
50	Seattle area	Washington	United States
51	Spokane	Washington	United States
52	Milwaukee	Wisconsin	United States