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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: April 1, 2008
Last updated: April 22, 2011
Last verified: April 2011

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 Intervention Phase
Transient Insomnia
Drug: Gabapentin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 1254
Study Start Date: August 2006
Study Completion Date: January 2007
Arms Assigned Interventions
Experimental: A Drug: Gabapentin
Gabapentin 50 mg oral capsule 30 minutes before bedtime


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00659100

  Show 35 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00659100     History of Changes
Other Study ID Numbers: A9451159
Study First Received: April 1, 2008
Last Updated: April 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents processed this record on November 27, 2014