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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Insomnia

Treatments: Drug: Placebo; Drug: PD 0200390

Study type: Interventional

Funder types: Industry

Identifiers

NCT00569972

A4251037

Details and patient eligibility

About

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

Enrollment: 682 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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682 participants in 5 patient groups

15 mg PD 0200390

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

30 mg PD 0200390

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

45 mg PD 0200390

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

60 mg PD 0200390

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Placebo PD 0200390

Experimental group

Treatment:

Drug: Placebo