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

February 11, 2009 updated by: Pfizer

PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab.
Experimental: PD 0200390, 5 mg
Drug: PD 0200390
Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
Drug: PD 0200390
Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
Drug: PD 0200390
Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
Experimental: PD 0200390, 15 mg
Drug: PD 0200390
Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
Drug: PD 0200390
Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
Drug: PD 0200390
Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
Experimental: PD 0200390, 30 mg
Drug: PD 0200390
Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
Drug: PD 0200390
Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
Drug: PD 0200390
Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Wake After Sleep Onset (WASO) as determined by PSG assessment
Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ)
Time Frame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Latency to persistent sleep (LPS) as determined by PSG assessment
Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Latency to REM Sleep as determined by PSG assessment
Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Sleep efficiency (SE) as determined by PSG assessment
Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Number of awakenings after sleep onset (NAASO) as determined by PSG assessment
Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Total wake time (TWT) as determined by PSG assessment
Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness
Time Frame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Number of arousals as determined by PSG assessment
Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Total sleep time (TST) as determined by PSG assessment
Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Next day performance sa determined by Digit Symbol Substitution Test (DSST)
Time Frame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ)
Time Frame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Wake time during sleep (WTDS) as determined by PSG assessment
Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Wake time after sleep (WTAS) as determined by PSG assessment
Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment
Time Frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D)
Time Frame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A4251026

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