A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment

Viatris

Status and phase: Completed; Phase 3

Conditions: Transient Insomnia

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00659100

A9451159

Details and patient eligibility

About

The purpose of this study is to assess consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (OTC) product label.

Enrollment: 1,254 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age of 18 years or older with symptoms of sleeplessness
• Provided informed consent

Exclusion criteria

• Contraindications to use of gabapentin

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,254 participants in 1 patient group

A

Experimental group

Treatment:

Drug: Gabapentin