Long-Term Effects of TAK-375 on Endocrine Function 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: Insomnia
Intervention: TAK-375 (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
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 was a study to evaluate the safety and efficacy of TAK-375 16 mg compared to placebo on
endocrine function taken once daily and for six months.
Clinical Details
Official title: A Phase III Safety Study to Evaluate the Long-Term Effects of TAK-375 on Endocrine Function in Adult Subjects With Chronic Insomnia
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Primary outcome: To determine if long-term administration of TAK-375 16 mg had an effect on endocrine function in subjects with chronic insomnia.
Secondary outcome: To confirm the safety profile of long-term administration of TAK-375 16 mg in subjects with chronic insomnia.
Detailed description:
Eligible subjects were randomly assigned to either TAK-375 16 mg or placebo once daily.
Subjects were instructed to take their assigned medication every night, and women were given
a luteinizing hormone surge home test kit and a menstrual diary to be maintained during the
Treatment Period. During the Treatment Period, subjects returned to the clinic on a monthly
basis for assessment of vital signs, adverse events, and concomitant medications, a pregnancy
test for women, and endocrine measurements. At the Month 3 Visit, an abbreviated physical
examination, a full battery of clinical laboratory tests, and a 12-lead ECG were performed.
The 6-month Treatment Period was followed by a 2-week Washout Period, during which subjects
did not take any study medication. After the 2-week Washout Period, subjects returned to the
clinic for a final visit.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The subject, if female, was nonpregnant, nonlactating, and had regular menses.
- The subject had primary insomnia as defined by the Diagnostic and Statistic Manual of
Mental Disorders, 4th Edition Revised (DSM-IV-TR™) for at least 3 months and a history
of daytime complaint(s) associated with disturbed sleep.
- The subject had a subjective sleep latency greater than or equal to 45 minutes and a
subjective total sleep time less than or equal to 6. 5 hours for at least 3 nights out
of 1 week.
- The subject's habitual bedtime was between 8: 30 PM and 12: 00 AM.
- The subject's habitual awakening time was between 5: 00 AM and 10: 00 AM.
- Subjects had serum prolactin, LH, FSH, ACTH, TSH, T3, and T4 within normal range.
Normal ranges for LH and FSH for women were defined as the lowest value among the
menstrual phases to the highest value among the menstrual phases.
- Men had serum testosterone values greater than or equal to 150 ng/dL.
- Women had serum estradiol values within normal range. Normal ranges for estradiol were
defined as the lowest value among the menstrual phases to the highest value among the
menstrual phases.
Exclusion Criteria:
- The subject had a known hypersensitivity to TAK-375 or related compounds, including
melatonin.
- The subject had previously participated in a study involving TAK-375.
- The subject had sleep schedule changes required by employment (eg, shift worker)
within 3 months prior to Day 1, or has flown across greater than 3 time zones within 7
days prior to Screening.
- The subject participated in a weight loss program or has substantially altered their
exercise routine within 30 days prior to Day 1.
- The subject had ever had a history of seizures, sleep apnea, chronic obstructive
pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental
retardation, or cognitive disorder.
- The subject had a history of psychiatric disorder (including anxiety or depression)
within the past 12 months.
- The subject used tobacco products during nightly awakenings.
- The subject 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 Day
1.
Locations and Contacts
Birmingham, Alabama, United States
Jasper, Alabama, United States
Peoria, Arizona, United States
Mesa, Arizona, United States
Los Angeles, California, United States
La Palma, California, United States
Riverside, California, United States
San Diego, California, United States
Denver, Colorado, United States
West Palm Beach, Florida, United States
Fort Lauderdale, Florida, United States
Roswell, Georgia, United States
Austell, Georgia, United States
Des Moines, Iowa, United States
Overland Park, Kansas, United States
Prairie Village, Kansas, United States
Florence, Kentucky, United States
Wentzville, Missouri, United States
South Plainfield, New Jersey, United States
Kenilworth, New Jersey, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Ninety Six, South Carolina, United States
Sioux Falls, South Dakota, United States
San Angelo, Texas, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Wichita Falls, Texas, United States
Additional Information
Starting date: January 2003
Ending date: July 2004
Last updated: May 2, 2008
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