NCT00551148

A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

PD 0200390 Dose-ranging Trial: A Randomized, Double-blind, Placebo-controlled, 5-way Crossover, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	PD 0200390	oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
DRUG	PD 0200390	oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
DRUG	PD 0200390	oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
DRUG	PD 0200390	oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
OTHER	Placebo	oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-10-30
• Last updated: 2012-07-25

Locations

16 sites across 1 country: United States