A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia

Pfizer

Status and phase: Withdrawn; Phase 2

Conditions: Insomnia

Treatments: Drug: Placebo; Drug: PD 0200390

Study type: Interventional

Funder types: Industry

Identifiers

NCT00748592

A4251026

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 3 month history of primary insomnia
• 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PD 0200390, 5 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

PD 0200390, 15 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

PD 0200390, 30 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390