NCT00784875

An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia

A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study of the Safety and Efficacy of LY2624803 in Outpatients With Insomnia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 643 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.

Detailed description

Outpatients with chronic insomnia who participate in this study will be treated in each of four 2-week treatment periods with bedtime doses of either placebo, zolpidem, LY2624803 1 mg, or LY2624803 3 mg. Neither patients nor investigators will be told what treatments are being given in any treatment period. A patient who completes all four treatment periods will be treated with placebo in 1, 2, or 3 of the periods; with zolpidem in 0, 1, or 2 of the periods; and with LY2624803 in either 1 or 2 of the periods. No patient will receive placebo for all four of the 2-week treatment periods. All patients will receive LY2624803 for at least one of the four 2-week treatment periods. During each treatment period, patients will record information each morning about their sleep the night before, and each evening about their functioning since waking up. Patients will also wear wrist actigraphy devices to record their physical activity. At the conclusion of each treatment period, patients will answer questions about their sleep, functioning, health, and relative preference for treatments.

Conditions

• Primary Insomnia
• Secondary Insomnia

Interventions

Type	Name	Description
DRUG	LY2624803	1 mg, oral capsule, once nightly before bedtime
DRUG	LY2624803	3 mg, oral capsule, once nightly before bedtime
DRUG	Placebo	matching placebo (capsule or tablet), once nightly before bedtime
DRUG	zolpidem	5 or 10 mg, oral tablet, once nightly before bedtime

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-11-04
• Last updated: 2012-02-29
• Results posted: 2012-02-29

Locations

49 sites across 1 country: United States