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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.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00659100
First received: April 1, 2008
Last updated: April 22, 2011
Last verified: April 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659100

  Show 35 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov 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:
Sleep Disorders, Intrinsic
Sleep Initiation and Maintenance Disorders
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
 Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on May 21, 2013