A Phase III Safety Study to Evaluate the Long-term Effects of TAK-375 on Endocrine Function in Adult Subjects With Chronic Insomnia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 122
- Primary Endpoint
- Change from baseline in Total Serum Thyroxine.
Study Overview
Brief Summary
The purpose of this study is to determine the long-term effects of Ramelteon, once daily (QD), on endocrine function values.
Detailed Description
Insomnia is characterized by a complaint of either difficulties initiating and maintaining sleep or of nonrestorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.
Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
This study has been designed to determine the long-term (6 month) effects of Ramelteon on endocrine function values. Study participation is anticipated to be about 7 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ramelteon 16 mg QD
Intervention: Ramelteon (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from baseline in Total Serum Thyroxine.
Time Frame: Months 1, 2, 3, 4, 5, and 6 or Final Visit
Secondary Outcomes
- Change from baseline in free thyroxine.(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in thyroid stimulating hormone.(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in triiodothyronine.(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in total testosterone (men only).(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in free testosterone (men only).(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in estradiol (women only).(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in prolactin.(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in follicle stimulating hormone (women only).(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in luteinizing hormone (women only).(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in luteinizing hormone surge (women only)(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in adrenocorticotropic hormone.(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in cortisol (AM).(Months 1, 2, 3, 4, 5, and 6 or Final Visit)
- Change from baseline in adrenocorticotropic hormone stimulation test.(Month 6 or Final Visit)