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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00666575
First received: April 23, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 23, 2008
April 23, 2008
December 2004
Not Provided
Adverse Events [ Time Frame: Day 45 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Pulse and Blood Pressure [ Time Frame: Day 45 ] [ Designated as safety issue: Yes ]
  • Subjective proportion of nights having difficulty sleeping [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
  • Subjective Sleep Latency [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
  • Subjective Wake After Sleep Onset [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
  • Subjective Number of Awakenings [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
  • Subjective Total Sleep Time [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
  • Subjective Assessment of Sleep Quality [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
  • Subjective Assessment of Ease of Awakening [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
  • Subject Global Evaluation [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
  • Pittsburg Sleep Quality Index [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Transient Insomnia
  • 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
  • Experimental: Gabapentin
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2105
May 2005
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Females who were pregnant or breastfeeding
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00666575
A9451146
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP