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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659100
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : April 26, 2011
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Transient Insomnia Drug: Gabapentin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1254 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 3-Month, Open-Label, Pharmacy-Based, Actual-Use Trial in a Simulated Over-The-Counter (OTC) Environment to Assess Self-Selection and Consumer Use Patterns of Gabapentin 250 mg for Occasional Sleeplessness
Study Start Date : August 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Drug: Gabapentin
Gabapentin 50 mg oral capsule 30 minutes before bedtime

Primary Outcome Measures :
  1. Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications) [ Time Frame: Throughout Day 90 ]
  2. Subject compliance with directions for use (number of capsules per dose and the number of doses per day) [ Time Frame: Throughout Day 90 ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Duration of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to use of gabapentin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00659100

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00659100     History of Changes
Other Study ID Numbers: A9451159
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents