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A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Transient Insomnia

Intervention: Gabapentin (Drug); Gabapentin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.

Clinical Details

Official title: A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Latency to persistent sleep as measured by polysomnography

Secondary outcome:

Subjective wake after sleep onset

Subjective total sleep time

Subjective assessment of sleep refreshment

Subjective assessment of sleep quality

Stanford Sleepiness Scale

Karolinska Sleep Diary-Sleep (KSD) Quality Index

KSD individual scores

Digit Symbol Substitution Test

Latency to REM sleep

Number of awakenings

Wake after sleep onset

Total wake time plus Stage 1 sleep

Total sleep time

Sleep efficiency

Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep

Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)

Vital signs

Adverse events

Sleep onset latency

Percent slow wave sleep (Stages 3&4 combined)

Subjective sleep latency

Subjective number of awakenings

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Aged >/= 18 years

- Females of child-bearing potential using medically-acceptable method of birth control

>/= 1 month prior to screening Exclusion Criteria:

- Current or recent history (within 2 years) of sleep disorder (excessive snoring,

obstructive sleep apnea, chronic painful condition)

- Recreational drug use within past 30 days

Locations and Contacts

Pfizer Investigational Site, Glendale, California 91206, United States

Pfizer Investigational Site, San Diego, California 92123, United States

Pfizer Investigational Site, Overland Park, Kansas 66211, United States

Pfizer Investigational Site, Overland Park, Kansas 66212, United States

Pfizer Investigational Site, New York, New York 10025, United States

Additional Information

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

Starting date: October 2004
Last updated: April 23, 2008

Page last updated: August 20, 2015

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