A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment
NCT00659100
Last updated date
ABOUT THIS STUDY
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 Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transient Insomnia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Age of 18 years or older with symptoms of sleeplessness
- Provided informed consent
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Contraindications to use of gabapentin
NEED INFO?
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Transient Insomnia | |||
| Intervention ICMJE | Drug: Gabapentin
Gabapentin 50 mg oral capsule 30 minutes before bedtime | |||
| Study Arms ICMJE | Experimental: A
Intervention: Drug: Gabapentin | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 1254 | |||
| Original Actual Enrollment ICMJE | 1257 | |||
| Actual Study Completion Date ICMJE | January 2007 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00659100 | |||
| Other Study ID Numbers ICMJE | A9451159 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||