A Study to Assess the Subjective Response to Treatment With TAK-375 in Adult Subjects With Chronic Insomnia
Information source: Takeda Global Research & Development Center, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Insomnia
Intervention: TAK-375 (Drug); placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Takeda Global Research & Development Center, Inc. Official(s) and/or principal investigator(s):
Stephen Sainati, MD, PhD, Study Director, Affiliation: Takeda Global Research & Development Center, Inc.
Summary
This study was a safety and efficacy study comparing TAK-375 8 mg to a placebo taken once
daily for two weeks in adult subjects with chronic insomnia.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Subjective Response to Treatment With TAK-375 in Adult Subjects With Chronic Insomnia by Utilizing an Interactive Voice Response System (IVRS) for Collecting Diary Data
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To assess the subjective response to treatment with TAK-375, based on diary data collected via an IVRS.
Secondary outcome: To evaluate the treatment effect of TAK-375 on sleep duration (mean subjective sleep latency [sSL] Nights 8 through 14; mean subjective total sleep time [sTST] Nights 1 through 7 and Nights 8 through 14) using the IVRS for collection of data.To evaluate the safety of TAK-375, through the record of adverse events (AEs), laboratory test results, vital signs, electrocardiogram (ECG) results, and physical examination findings.
Detailed description:
The study consisted of 2 Screening Periods (a 7-day period of procedures and washout of
pharmacologic sleep aids, and a 7-day single-blind placebo phase for recording sSL and sTST);
a Randomization visit (Day 1); an Interim Double-Blind visit after 7 days' of double-blind
study medication (Day 8); and a Final visit (Day 15) (or Early Termination visit). At
Screening visit 2, qualified subjects participating in this study received single-blind study
medication (placebo). At the Randomization visit (Day 1), subjects received placebo or
TAK-375 8 mg to be taken once daily for 15 days, depending on the study medication to which
they had been randomized.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Female subjects of childbearing potential must be nonpregnant and nonlactating and
agree to use an approved method of contraception during the study.
- Based on sleep history, the subject has had chronic insomnia as defined by the
DSM-IV-TRTM for at least 3 months.
- Based on sleep history, the subject reports a history of sSL ≥60 min and a sTST <6. 5
hours.
- Based on sleep history, the subject's habitual bedtime is between 10: 00 PM and 1: 00
AM.
- The subject is willing to have a fixed bedtime and agrees to go to bed within +/- 30
minutes of the habitual bedtime during the entire study.
- Subjects have consistent access to a touch tone phone and are willing to complete
telephone questionnaires twice daily during participation in the study.
- The subject is willing to remain in bed for at least 6. 5 hours each night during the
entire study.
- Based on sleep history, the subject uses pharmacological assistance to sleep 0-4 times
per week in the last 3 months. Subjects must agree to discontinue the use of all
pharmacological sleep aids beginning one week prior to the first dose of single-blind
study medication and throughout the entire duration of the study.
Exclusion Criteria:
- The subject has a known hypersensitivity to TAK-375 or related compounds, including
melatonin, and 5-hydroxytryptophan.
- The subject has participated in any other investigational study and/or taken any
investigational drug within 30 days prior to the first dose of single-blind study
medication.
- The subject has sleep schedule changes required by employment (eg, shift worker)
within 3 months prior to the first night of single-blind study medication.
- The subject 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.
- The subject has participated in a weight loss program or has substantially altered
their exercise routine within 30 days prior to the first night of singleblind study
medication.
- The subject has ever had a history of seizures, sleep apnea, and/or COPD.
- The subject has a history of psychiatric disorder (including anxiety, depression,
mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the
past 12 months.
- The subject uses tobacco products or any other products that may interfere with the
sleep wake cycle during nightly awakenings.
- The subject has used any central nervous system medication within 1 week (or 5 half
lives of the drug, whichever is longer) prior to the first dose of singleblind study
medication. These medications must not have been used to treat psychiatric disorders.
- The subject has used melatonin, or other drugs or supplements known to affect
sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer)
prior to the first dose of single-blind study medication. The subject intends to
continue taking any disallowed medication or any prescription medication or over-the
counter (OTC) medication that is known to affect the sleep/wake function or otherwise
interfere with evaluation of the study medication. The subject must report all
prescription and OTC medications taken in the 3 weeks prior to screening.
Locations and Contacts
Scottsdale, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Hot Springs, Arkansas, United States
Oakland, California, United States
La Jolla, California, United States
La Mesa, California, United States
Cerritos, California, United States
Denver, Colorado, United States
Fort Lauderdale, Florida, United States
Brandon, Florida, United States
Fort Myers, Florida, United States
Pinellas Park, Florida, United States
Deland, Florida, United States
Bay Harbor Island, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Clearwater, Florida, United States
Hollywood, Florida, United States
Vero Beach, Florida, United States
Atlanta, Georgia, United States
Austell, Georgia, United States
Macon, Georgia, United States
Boise, Idaho, United States
Northbrook, Illinois, United States
Wichita, Kansas, United States
Prairie Village, Kansas, United States
Louisville, Kentucky, United States
Frederick, Maryland, United States
Moorestown, New Jersey, United States
Williamsville, New York, United States
New York, New York, United States
Menlius, New York, United States
Winston-Salem, North Carolina, United States
Salem, North Carolina, United States
Cincinnati, Ohio, United States
Mogadore, Ohio, United States
Philadelphia, Pennsylvania, United States
Chattanooga, Tennessee, United States
Bristol, Tennessee, United States
Dallas, Texas, United States
Fairfax, Virginia, United States
Tacoma, Washington, United States
Additional Information
Starting date: February 2005
Ending date: August 2005
Last updated: May 2, 2008
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