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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

784 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-01-31

Brief Summary

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The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.

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Detailed Description

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Conditions

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Transient Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Gabapentin 250 mg

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime

Gabapentin 500 mg

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Gabapentin 500 mg oral capsule 30 minutes prior to bedtime

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo 30 minutes prior to bedtime

Interventions

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Gabapentin

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime

Intervention Type DRUG

Gabapentin

Gabapentin 500 mg oral capsule 30 minutes prior to bedtime

Intervention Type DRUG

Placebo

Matched placebo 30 minutes prior to bedtime

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No