Efficacy and Safety of Ramelteon on Chronic Insomnia

NCT00915135 | Completed Phase 2 DMC

• 2 other identifiers: TAK-375-CCT-001U1111-1115-2062
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Insomnia

Keywords

Insomnia; Sleep Initiation and Maintenance Disorders; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Mean Latency to Persistent Sleep

  Mean of Nights 1 and 2.

Secondary Outcomes (11)

• Mean Total Sleep Time

  Mean of Nights 1 and 2.

• Sleep Efficiency

  Mean of Nights 1 and 2

• Awake Time after Persistent Sleep

  Mean of Nights 1 and 2.

• Percent of Total Sleep Time in NREM sleep Stage 1

  Mean of Nights 1 and 2.

• Percent of Total Sleep Time in NREM sleep Stage 2

  Mean of Nights 1 and 2.

Study Arms (1)

Ramelteon QD and Placebo QD (25 possible combinations total)

EXPERIMENTAL

Drug: Ramelteon and Placebo (25 possible combinations total)

Interventions

Ramelteon and Placebo (25 possible combinations total) DRUG

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

Also known as: Ramelteon, Rozerem, TAK-375

Ramelteon QD and Placebo QD (25 possible combinations total)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Related Links

• Rozerem Package Insert.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 5, 2009
• Study Start: May 1, 2002
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: June 2, 2010

Record last verified: 2010-05