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A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00666575
Enrollment
2105
Registered
2008-04-25
Start date
2004-12-31
Completion date
2005-05-31
Last updated
2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transient Insomnia

Brief summary

The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness

Interventions

DRUGGabapentin

Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days

DRUGPlacebo

Matched placebo oral capsule 30 minutes prior to bedtime for 28 days

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subjects \>/= 12 years of age who reported occasional sleeplessness in month prior to screening

Exclusion criteria

* Females who were pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frame
Adverse EventsDay 45

Secondary

MeasureTime frame
Subjective proportion of nights having difficulty sleepingDay 45
Subjective Sleep LatencyDay 45
Subjective Wake After Sleep OnsetDay 45
Subjective Number of AwakeningsDay 45
Pulse and Blood PressureDay 45
Subjective Assessment of Sleep QualityDay 45
Subjective Assessment of Ease of AwakeningDay 45
Subject Global EvaluationDay 45
Pittsburg Sleep Quality IndexDay 45
Subjective Total Sleep TimeDay 45

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026