Transient InsomniaPhase 3NCT00659100
A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment
A Phase 3 study testing Gabapentin in people with Transient Insomnia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 35 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Insomnia
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,254 participants
- Where
- 35 sitesUnited States
- Study dates
- Aug 2006to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older with symptoms of sleeplessness
- Provided informed consent
Who cannot join
- Contraindications to use of gabapentin
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87104
Pfizer Investigational Site
Albuquerque, New Mexico, 87110
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Baltimore, Maryland, 21228
Pfizer Investigational Site
Belton, Missouri, 64012
Pfizer Investigational Site
Bonita, California, 91902
Pfizer Investigational Site
Bountiful, Utah, 84010
Pfizer Investigational Site
Cary, North Carolina, 27513
Pfizer Investigational Site
Chapel Hill, North Carolina, 27514
Pfizer Investigational Site
Elk River, Minnesota, 55330
Pfizer Investigational Site
Fallbrook, California, 92028
Pfizer Investigational Site
Falls Church, Virginia, 22041
Pfizer Investigational Site
Hacienda Heights, California, 91746
Pfizer Investigational Site
Holly Springs, Mississippi, 38625
Pfizer Investigational Site
Houston, Texas, 77088
Pfizer Investigational Site
Independence, Missouri, 64054
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
Northfield, Minnesota, 55057
Pfizer Investigational Site
Oceanside, California, 92054
Pfizer Investigational Site
Ogden, Utah, 84401
Pfizer Investigational Site
Orange, California, 92866
Pfizer Investigational Site
Pearland, Texas, 77581
Pfizer Investigational Site
Pembroke Pines, Florida, 33026
Pfizer Investigational Site
Raleigh, North Carolina, 27606
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Raleigh, North Carolina, 27612
Pfizer Investigational Site
Red Wing, Minnesota, 55066
Pfizer Investigational Site
Richmond, Virginia, 23233
Pfizer Investigational Site
Saint Louis Park, Minnesota, 55426
Pfizer Investigational Site
Salt Lake City, Utah, 84121
Pfizer Investigational Site
San Dimas, California, 91773
Pfizer Investigational Site
Syracuse, Utah, 84075
Pfizer Investigational Site
Taos, New Mexico, 87571
Pfizer Investigational Site
West Valley City, Utah, 84120
Pfizer Investigational Site
Weston, Florida, 33326
About this study
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
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.
- Conditions
- Transient Insomnia
- Being tested
- Gabapentin
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Gabapentin 50 mg oral capsule 30 minutes before bedtime
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)
Measured: Throughout Day 90
Subject compliance with directions for use (number of capsules per dose and the number of doses per day)
Measured: Throughout Day 90
Secondary outcomes (1)
Adverse events
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startAug 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659100
- Sponsor's protocol ID
- A9451159
- Status last verified
- Apr 2011
- First submitted
- 1 Apr 2008
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00659100
- Acronym / sponsor ID
- A9451159
- Conditions
- Transient Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,254 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Gabapentin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 18 years or older with symptoms of sleeplessness
- Provided informed consent
Key exclusion criteria (1 listed)
- Contraindications to use of gabapentin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinGabapentin 50 mg oral capsule 30 minutes before bedtime | Drug | A |
Primary outcome
Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)
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
1 secondary outcome
Adverse events
Time frame: Duration of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Transient Insomnia
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Sleep Restriction Therapy for Insomnia in Primary Health Care
Insomnia
Not yet recruitingPhase 2
SM-1 vs. an Active Comparator in A Model of Transient Insomnia
Transient Insomnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin in people with Transient Insomnia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications) (time frame: Throughout Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.