A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness

Verified by: Pfizer, April 2008
First Received: April 23, 2008 | Last Updated: April 23, 2008 | Phase: Phase 3 | Start Date: December 2004
Overall Status: Completed | Estimated Enrollment: 2105
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

To obtain contact information for a study center near you, click here.

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00666575