Trial intelligence / Profile preview

Safety Study of Ramelteon on Endocrine Function in Chronic Insomnia

NCT00656994Phase 3

Key facts

Status: Completed
Start: Jan 2003
Primary completion: Jul 2004
Countries: 1
Sponsor: Takeda
Modality: Small Molecules

Drugs: ramelteon
Conditions: Insomnia

Overview

Phase 3, randomised, double-blind trial in Insomnia comparing Ramelteon 16 mg QD with Placebo (2 arms). Primary endpoint: Change from baseline in Total Serum Thyroxine at 6 months. Started Jan 2003; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Ramelteon 16 mg QD
Ramelteon 16 mg tablets once nightly
Placebo
Placebo-matching tablets once nightly

Who it enrols

Adults with chronic insomnia, BMI 18-34, normal endocrine function at baseline, and no significant psychiatric or substance abuse history.

Endpoints

Primary

Change from baseline in Total Serum Thyroxine6 months

Secondary

Change from baseline in free thyroxine6 months
Change from baseline in thyroid stimulating hormone6 months
Change from baseline in triiodothyronine6 months
Change from baseline in total testosterone (men only)6 months
Change from baseline in free testosterone (men only)6 months
Change from baseline in estradiol (women only)6 months
Change from baseline in prolactin6 months
Change from baseline in follicle stimulating hormone (women only)6 months

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