A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

Transient Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674752
• Other study ID #: A9451157
• Status: Completed
• Phase: Phase 3
• Start date: March 2006
• Est. completion date: August 2006

Study information

• Verified date: April 2011
• 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 on polysomnographic assessments in transient insomnia induced by a sleep phase advance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged >/= 18 years who reported occasional sleeplessness in the month prior to screening

• 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)

• Currently taking or expected to take any of the following during the trial:

amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders
• Transient Insomnia

Intervention

Drug:
• Gabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
• Gabapentin
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
• Placebo
Matched placebo oral capsule 30 minutes prior to bedtime

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Overland Park	Kansas

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	Wake after sleep onset as measured by polysomnography (PSG)		Hour +8
Secondary	PSG Latency to Persistent Sleep		Hour +8
Secondary	PSG Wake Time During Sleep		Hour +8
Secondary	PSG WASO		Hour +8
Secondary	PSG Sleep Onset Latency		Hour +8
Secondary	Vital signs		Hour +8
Secondary	Karolinska Sleep Diary-Sleep (KSD) Quality Index		Hour +8
Secondary	KSD individual scores		Hour +8
Secondary	PSG NA		Hour +8
Secondary	Adverse events		Hour +13
Secondary	PSG Total wake time plus Stage 1 sleep		Hour +8
Secondary	PSG TST		Hour +8
Secondary	PSG Sleep Efficiency		Hour +8
Secondary	PSG Percent of Stages 1, 2, 3, 4 and REM sleep		Hour +8
Secondary	PSG Percent slow wave sleep (Stages 3&4 combined)		Hour +8
Secondary	subjective Sleep Latency		Hour +8
Secondary	subjective Number of Awakenings (NA)		Hour +8
Secondary	subjective Wake After Sleep Onset (WASO)		Hour +8
Secondary	subjective Total Sleep Time (TST)		Hour +8
Secondary	subjective Assessment of Sleep Refreshment		Hour +8
Secondary	subjective Assessment of Sleep Quality		Hour +8

External Links

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