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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00915135
Other study ID # TAK-375-CCT-001
Secondary ID U1111-1115-2062
Status Completed
Phase Phase 2
First received June 3, 2009
Last updated May 31, 2010
Start date May 2002
Est. completion date December 2003

Study information

Verified date May 2010
Source Takeda
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in Japanese subjects with Chronic Insomnia


Description:

Complaints of sleep disorder are increasing with today's aging society and changing lifestyle. Sleep disorders not only impact one's activities of daily living, but also impede one's social life, leading to reduced productivity and sometimes accidents through carelessness.

Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 2003
Est. primary completion date December 2003
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- Has primary chronic insomnia for at least 3 months.

- Has a mean latency of greater than or equal to 20 minutes on 2 consecutive polysomnography screening nights with no night less than 15 minutes, and has a mean of at least 60 minutes of wake time across 2 nights with no night less than 45 minutes.

- Has a habitual bedtime between 8:30 PM and 12:00 AM.

- Has a body mass index that is not less than 17, but less than 34.

- Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

- Has a history of psychiatric disorder (including depression and anxiety), seizures, drug addiction, sleep apnea, nocturnal myoclonus and/or mental retardation as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.

- Has a history of alcohol abuse within the previous 2 years.

- Has a hepatic disease, and a significant neurological, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological or metabolic disease.

- Has a known hypersensitivity to ramelteon or related compounds, including melatonin.

- Has a positive hepatitis panel including hepatitis A, hepatitis B or hepatitis C.

- Has any clinically abnormal findings as determined by a medical history, physical examination, electrocardiogram or clinical laboratory tests by the investigator or sub investigator.

- Has experienced 3 hours or more of jet lag within 7 days preceding the polysomnography screening.

- Has an apnea-hypopnea index (per hour of sleep) greater than or equal to 10 as seen on the first night of polysomnography screening.

- Has periodic limb movement with arousal index (per hour o sleep) greater than or equal to 10 as seen on the first night of polysomnography screening.

- Has participated in an excessive weight loss program that may have given influence on the evaluation of this study, or altered the participant's exercise routine within 30 days prior to double-blind study medication administration.

- Has had a clinically significant illness within 30 days prior to double-blind study medication administration.

- Has had sleep schedule changes required by employment (e.g., shift worker) within 3 months prior to double-blind study medication administration.

- The investigator or sub investigator judges the study subject inappropriate for participation because it is considered difficult to complete the study, or participating in the study will not be in the best interest of the subject.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ramelteon and Placebo (25 possible combinations total)
Randomized sequence over two consecutive nights for a total of five treatment periods to include the following: Ramelteon 4 mg, tablets, orally over two nights Ramelteon 8 mg, tablets, orally over two nights Ramelteon 16 mg, tablets, orally over two nights Ramelteon 32 mg, tablets, orally over two nights Ramelteon placebo-matching tablets, orally over two nights

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Latency to Persistent Sleep Mean of Nights 1 and 2. No
Secondary Mean Total Sleep Time Mean of Nights 1 and 2. No
Secondary Sleep Efficiency Mean of Nights 1 and 2 No
Secondary Awake Time after Persistent Sleep Mean of Nights 1 and 2. No
Secondary Percent of Total Sleep Time in NREM sleep Stage 1 Mean of Nights 1 and 2. No
Secondary Percent of Total Sleep Time in NREM sleep Stage 2 Mean of Nights 1 and 2. No
Secondary Percent of Total Sleep Time in NREM sleep Stage 3/4 Mean of Nights 1 and 2. No
Secondary Percent of Total Sleep Time in REM sleep Stage Mean of Nights 1 and 2. No
Secondary Latency to REM sleep stage Mean of Nights 1 and 2. No
Secondary Subjective Sleep Latency Mean of Nights 1 and 2. No
Secondary Subjective Total Sleep Time Mean of Nights 1 and 2. No
Secondary Subjective Sleep Quality Mean of Nights 1 and 2. No
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