Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Gabapentin
  • Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days
• Drug: Placebo
  • Matched placebo oral capsule 30 minutes prior to bedtime for 28 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Gabapentin
• Placebo Comparator: Placebo

Primary Measures

• Adverse Events
  • Time Frame: Day 45
    Safety Issue?: Yes

Secondary Measures

• Pulse and Blood Pressure
  • Time Frame: Day 45
    Safety Issue?: Yes
• Subjective proportion of nights having difficulty sleeping
  • Time Frame: Day 45
    Safety Issue?: No
• Subjective Sleep Latency
  • Time Frame: Day 45
    Safety Issue?: No
• Subjective Wake After Sleep Onset
  • Time Frame: Day 45
    Safety Issue?: No
• Subjective Number of Awakenings
  • Time Frame: Day 45
    Safety Issue?: No
• Subjective Total Sleep Time
  • Time Frame: Day 45
    Safety Issue?: No
• Subjective Assessment of Sleep Quality
  • Time Frame: Day 45
    Safety Issue?: No
• Subjective Assessment of Ease of Awakening
  • Time Frame: Day 45
    Safety Issue?: No
• Subject Global Evaluation
  • Time Frame: Day 45
    Safety Issue?: No
• Pittsburg Sleep Quality Index
  • Time Frame: Day 45
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• Females who were pregnant or breastfeeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666575

Study ID Number: A9451146

ClinicalTrials.gov Identifier: NCT00666575

Health Authority: United States: Food and Drug Administration

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