Transient InsomniaPhase 3NCT00666575
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
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 23 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 12 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?
- Yes, some participants may receive a placebo
- How many people
- 2,105 participants
- Where
- 23 sitesUnited States
- Study dates
- Dec 2004to May 2005
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects >/= 12 years of age who reported occasional sleeplessness in month prior to screening
Who cannot join
- Females who were pregnant or breastfeeding
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Beverly Hills, California, 90211
Pfizer Investigational Site
Boise, Idaho, 83704
Pfizer Investigational Site
Boise, Idaho, 83712
Pfizer Investigational Site
Clearwater, Florida, 33765
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Fort Worth, Texas, 76135
Pfizer Investigational Site
Indianapolis, Indiana, 46250
Pfizer Investigational Site
Las Vegas, Nevada, 89104
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Phoenix, Arizona, 85018
Pfizer Investigational Site
Salt Lake City, Utah, 84102
Pfizer Investigational Site
San Antonio, Texas, 78205
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Francisco, California, 94102
Pfizer Investigational Site
Santa Fe, New Mexico, 87505
Pfizer Investigational Site
West Jordan, Utah, 84088
Pfizer Investigational Site
West Palm Beach, Florida, 33409
About this study
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
- Conditions
- Transient Insomnia
- Being tested
- Gabapentin, Placebo
- 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 500 mg oral capsule 30 minutes prior to bedtime for 28 days
PlaceboDrug
Matched placebo oral capsule 30 minutes prior to bedtime for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Not described Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Day 45
Secondary outcomes (10)
Pulse and Blood Pressure
Measured: Day 45
Subjective proportion of nights having difficulty sleeping
Measured: Day 45
Subjective Sleep Latency
Measured: Day 45
Subjective Wake After Sleep Onset
Measured: Day 45
Subjective Number of Awakenings
Measured: Day 45
Subjective Total Sleep Time
Measured: Day 45
Subjective Assessment of Sleep Quality
Measured: Day 45
Subjective Assessment of Ease of Awakening
Measured: Day 45
Subject Global Evaluation
Measured: Day 45
Pittsburg Sleep Quality Index
Measured: Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startDec 2004
- Study completionMay 2005
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,105 participants (estimated)
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
- NCT00666575
- Sponsor's protocol ID
- A9451146
- Status last verified
- Apr 2008
- First submitted
- 23 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 Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population
- ClinicalTrials.gov ID
- NCT00666575
- Acronym / sponsor ID
- A9451146
- Conditions
- Transient Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,105 participants (estimated)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- May 2005 (actual)
- First posted
- 25 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 the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: Gabapentin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects >/= 12 years of age who reported occasional sleeplessness in month prior to screening
Key exclusion criteria (1 listed)
- Females who were pregnant or breastfeeding
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 500 mg oral capsule 30 minutes prior to bedtime for 28 days | Drug | Gabapentin |
| PlaceboMatched placebo oral capsule 30 minutes prior to bedtime for 28 days | Drug | Placebo |
Primary outcome
Adverse Events
Time frame: Day 45
10 secondary outcomes
Pulse and Blood Pressure
Time frame: Day 45
Subjective proportion of nights having difficulty sleeping
Time frame: Day 45
Subjective Sleep Latency
Time frame: Day 45
Subjective Wake After Sleep Onset
Time frame: Day 45
Subjective Number of Awakenings
Time frame: Day 45
Subjective Total Sleep Time
Time frame: Day 45
Subjective Assessment of Sleep Quality
Time frame: Day 45
Subjective Assessment of Ease of Awakening
Time frame: Day 45
Subject Global Evaluation
Time frame: Day 45
Pittsburg Sleep Quality Index
Time frame: Day 45
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
Active, not recruiting
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
23 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 23 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 1 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 23 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. Some participants in this study may receive a placebo. 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?
Adverse Events (time frame: Day 45). 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.