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

Viatris

Status and phase: Completed; Phase 3

Conditions: Transient Insomnia

Treatments: Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00666575

A9451146

Details and patient eligibility

About

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

Enrollment: 2,105 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Females who were pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,105 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Treatment:

Drug: Gabapentin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo