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

Transient Insomnia Clinical Trial

Official title:

A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study Of Gabapentin 100 mg and 250 mg in Transient Insomnia Induced By A Sleep Phase Advance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666939
• Other study ID #: A9451141
• Status: Completed
• Phase: Phase 3
• Start date: October 2004
• Est. completion date: January 2005

Study information

• Verified date: April 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 773
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders
• Transient Insomnia

Intervention

Drug:
• Gabapentin
Gabapentin 100 mg oral capsule 30 minutes prior to bedtime
• Gabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
• Placebo
Matched placebo 30 minutes prior to bedtime

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Duncansville	Pennsylvania
United States	Pfizer Investigational Site	Johnstown	Pennsylvania
United States	Pfizer Investigational Site	Metairie	Louisiana
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Thornwood	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective sleep latency		Hour +8
Secondary	Stanford Sleepiness Scale		Hour +13
Secondary	Vital signs		Hour +8
Secondary	Adverse events		Hour +13
Secondary	Subjective number of awakenings		Hour +8
Secondary	Subjective wake after sleep onset		Hour +8
Secondary	Subjective total sleep time		Hour +8
Secondary	Subjective assessment of sleep refreshment		Hour +8
Secondary	Subjective assessment of sleep quality		Hour +8
Secondary	Karolinska Sleep Diary-Sleep (KSD) Quality Index		Hour +8
Secondary	KSD individual scores		Hour +8
Secondary	Digit Symbol Substitution Test		Hour +8
Secondary	Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)		Hour +8

External Links

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