Trial intelligence / Profile preview

Ramelteon in Adults With Chronic Insomnia

NCT00671125Phase 3

Key facts

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

Drugs: ramelteon
Conditions: Insomnia

Overview

Phase 3, randomised, double-blind trial of ramelteon in Insomnia (3 arms), sponsored by Takeda. Primary endpoint: Mean Latency to Persistent Sleep at Week 1. Started Jan 2003; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Ramelteon 8 mg
Ramelteon 8 mg QD
Ramelteon 16 mg
Ramelteon 16 mg QD
Placebo
Placebo QD

Who it enrols

Adults with chronic primary insomnia, defined by subjective and PSG criteria, without significant other medical or psychiatric conditions.

Endpoints

Primary

Mean Latency to Persistent SleepWeek 1

Secondary

Mean Latency to Persistent SleepWeek 5
Total Sleep TimeWeek 5
Sleep EfficiencyWeek 5
Awake Time after Persistent SleepWeek 5
Number of Awakenings after Persistent SleepWeek 5
Subjective Sleep LatencyWeek 5
Subjective Total Sleep TimeWeek 5
Subjective Sleep QualityWeek 5

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