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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00748592
• Other study ID #: A4251026
• Status: Withdrawn
• Phase: Phase 2
• First received: September 5, 2008
• Last updated: February 11, 2009
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: February 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wake After Sleep Onset (WASO) as determined by PSG assessment		Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23	No
Secondary	Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ)		Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24	No
Secondary	Latency to persistent sleep (LPS) as determined by PSG assessment		Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23	No
Secondary	Latency to REM Sleep as determined by PSG assessment		Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23	No
Secondary	Sleep efficiency (SE) as determined by PSG assessment		Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23	No
Secondary	Number of awakenings after sleep onset (NAASO) as determined by PSG assessment		Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23	No
Secondary	Total wake time (TWT) as determined by PSG assessment		Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23	No
Secondary	Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness		Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24	No
Secondary	Number of arousals as determined by PSG assessment		Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23	No
Secondary	Total sleep time (TST) as determined by PSG assessment		Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23	No
Secondary	Next day performance sa determined by Digit Symbol Substitution Test (DSST)		Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24	No
Secondary	Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ)		Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24	No
Secondary	Wake time during sleep (WTDS) as determined by PSG assessment		Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23	No
Secondary	Wake time after sleep (WTAS) as determined by PSG assessment		Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23	No
Secondary	Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment		Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23	No
Secondary	Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D)		Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24	No

External Links

•   To obtain contact information for a study center near you, click here.