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...
Date First Received: April 1, 2008
Last Updated: May 5, 2008
Verified by: Pfizer, May 2008
Clinical Trial Phase: Phase 3 | Start Date: August 2006
Overall Status: Completed
Estimated Enrollment: 1257
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Intervention(s) in this Clinical Trial
- Drug: Gabapentin
- Gabapentin 50 mg oral capsule 30 minutes before bedtime
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: A
Outcome Measures for this Clinical Trial
Primary 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
Safety Issue?: Yes
- Time Frame: Throughout Day 90
- Subject compliance with directions for use (number of
capsules per dose and the number of doses per day)
- Time Frame: Throughout Day 90
Safety Issue?: Yes
- Time Frame: Throughout Day 90
Secondary Measures
- Adverse events
- Time Frame: Duration of study
Safety Issue?: Yes
- Time Frame: Duration of study
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Age of 18 years or older with symptoms of sleeplessness
- Provided informed consent
Exclusion Criteria:
- Contraindications to use of gabapentin
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00659100
Study ID Number: A9451159
ClinicalTrials.gov Identifier: NCT00659100
Health Authority: United States: Food and Drug Administration
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