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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00569972

Enrollment

682

Registered

2007-12-10

Start date

2007-10-31

Completion date

2009-01-31

Last updated

2012-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Brief summary

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

Interventions

DRUGPD 0200390

Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days

DRUGPlacebo

Matched oral placebo for weeks 2-7.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia.	Weekly
To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia.	Weekly
To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia.	Weekly
To characterize the dose response relationship of PD 0200390 on subjective assessments of latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO) and total sleep time (sTST) in subjects with primary insomnia.	Weekly
To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia.	Weekly

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026