Long-Term Effects of TAK-375 on Endocrine Function in Adult Subjects With Chronic Insomnia - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00656994

Purpose

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.

Condition	Intervention	Phase
Insomnia	Drug: TAK-375 Drug: placebo	Phase III

Drug Information available for: Ramelteon

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
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

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

To determine if long-term administration of TAK-375 16 mg had an effect on endocrine function in subjects with chronic insomnia. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To confirm the safety profile of long-term administration of TAK-375 16 mg in subjects with chronic insomnia. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Enrollment:	122
Study Start Date:	January 2003
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental TAK-375, 16 mg tablet	Drug: TAK-375 TAK-375, 16 mg tablet, orally, daily for 6 months
2: Placebo Comparator Placebo tablet	Drug: placebo placebo, tablet, orally, daily for 6 months

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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656994

Show 29 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Stephen Sainati, MD, PhD

Takeda Global Research & Development Center, Inc.

More Information

Responsible Party:	Takeda Global Research & Development Center, Inc. ( VP, Clinical Science )
Study ID Numbers:	01-02-TL-375-032
Study First Received:	March 12, 2008
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00656994
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Sleep Disorder
Insomnia

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009