A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• 3 month history of primary insomnia;

• 18 to 64 years

• For the last 3 months-regularly awake unrefreshed and unrestored

• Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)

Exclusion Criteria:

• Any history of an Axis 1 psychiatric diagnosis;

• History or presence of any breathing related sleep disorder;

• History or presence of any medical or neurological condition that could interfere with sleep

• Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week