Ramelteon in Adults With Chronic Insomnia

NCT00671567 | Completed Phase 3

• 2 other identifiers: 01-02-TL-375-020U1111-1114-3130
• Study Type: interventional
• Target: 848
• Locations: 1 country
• Sites: 70

Brief Summary

The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in adult subjects with chronic insomnia.

Conditions

Chronic Insomnia

Keywords

Sleep Disorder; Insomnia

Outcome Measures

Primary Outcomes (1)

• Mean Subjective Sleep Latency per subject diary, from Nights 1 through 7 of double-blind treatment.

  Weeks 1, 2, 3, 4, and 5 or Final Visit

Secondary Outcomes (6)

• Mean Subjective Sleep Latency per subject diary, over the week preceding the Day 15, Day 22, Day 29, and Day 36 Visits.

  Weeks 2, 3, 4, and 5 or Final Visit

• Subjective Total Sleep Time

  Weeks 1, 2, 3, 4, and 5 or Final Visit

• Subjective Number of Awakenings.

  Weeks 1, 2, 3, 4, and 5 or Final Visit

• Subjective Ease of Falling Back to Sleep after Awakening.

  Weeks 1, 2, 3, 4, and 5 or Final Visit

• Subjective Sleep Quality.

  Weeks 1, 2, 3, 4, and 5 or Final Visit

Study Arms (3)

Ramelteon 8 mg QD

EXPERIMENTAL

Drug: Ramelteon

Ramelteon 16 mg QD

EXPERIMENTAL

Drug: Ramelteon

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramelteon DRUG

Ramelteon, 8 mg, tablets, orally, once daily for up to 5 weeks.

Also known as: Rozerem™, TAK-375

Ramelteon 8 mg QD

Placebo DRUG

Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Has had primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Text Revision and a history of daytime complaint(s) associated with disturbed sleep.
• Subjective sleep latency greater than or equal to 45 minutes and a subjective total sleep time less than or equal to 6.5 hours per night for at least 3 nights during the week of the lead-in period, based on subject diary.
• Habitual bedtime is between 8:30 PM and 12:00 AM.
• Body mass index between 18 and 34, inclusive.

You may not qualify if:

• Known hypersensitivity to Ramelteon or related compounds, including melatonin.
• Previously participated in a study involving Ramelteon.
• Participated in any other investigational study, and/or taken any investigational drug within 30 days or five half-lives prior to the first day of single-blind study medication, whichever is longer.
• Sleep schedule changes required by employment (eg, shift worker) within three months prior to the first day of single-blind study medication, or has flown across greater than three time zones within seven days prior to screening.
• Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first day of single-blind study medication.
• Has ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
• History of psychiatric disorder (including anxiety or depression) within the past 12 months.
• History of drug addiction or drug abuse within the past 12 months.
• History of alcohol abuse within the past 12 months.
• Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic or metabolic disease unless currently controlled and stable with protocol-allowed medication 30 days prior to the first day of single-blind study medication.
• Uses tobacco products during nightly awakenings.
• Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
• Positive hepatitis panel.
• Any additional condition that in the Investigator's opinion would:
• Affect sleep-wake function

Sponsors & Collaborators

• Takeda: lead

Study Sites (70)

Unknown Facility

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tempe, Arizona, United States

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Chula Vista, California, United States

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Irvine, California, United States

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La Mesa, California, United States

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Newport Beach, California, United States

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Northridge, California, United States

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Oakland, California, United States

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Redlands, California, United States

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Spring Valley, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Clearwater, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Longwood, Florida, United States

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Pembroke Pines, Florida, United States

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Safety Harbor, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Blairsville, Georgia, United States

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Decatur, Georgia, United States

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Macon, Georgia, United States

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Marietta, Georgia, United States

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Arlington Heights, Illinois, United States

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Chicago, Illinois, United States

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Danville, Indiana, United States

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Evansville, Indiana, United States

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Shawnee Mission, Kansas, United States

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Bethesda, Maryland, United States

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Brockton, Massachusetts, United States

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Detroit, Michigan, United States

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Hattiesburg, Mississippi, United States

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St Louis, Missouri, United States

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Lawrenceville, New Jersey, United States

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Moorestown, New Jersey, United States

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Albuquerque, New Mexico, United States

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Mineola, New York, United States

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Williamsville, New York, United States

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Cary, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Mt. Pleasant, South Carolina, United States

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Johnson City, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Virginia Beach, Virginia, United States

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Gig Harbor, Washington, United States

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Related Links

• Rozerem Package Insert

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• VP, Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: December 1, 2002
• Primary Completion: September 1, 2003
• Study Completion: September 1, 2003
• Last Updated: November 20, 2012

Record last verified: 2012-11

Locations

US (70)