Transient InsomniaPhase 3NCT00666770
A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
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 5 sites in United States.
Trial summary
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia. 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?
- Yes, some participants may receive a placebo
- How many people
- 309 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2004to Nov 2004
- 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
- Aged >/= 18 years
- Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening
Who cannot join
- Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
- Recreational drug use within past 30 days
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
New York, New York, 10025
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
San Diego, California, 92123
About this study
Official title: A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.
- 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 250 mg oral capsule 30 minutes prior to bedtime
GabapentinDrug
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
PlaceboDrug
Matched placebo 30 minutes prior to bedtime
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin 250 mg | Experimental | Not described Receives: Drug: Gabapentin |
| Gabapentin 500 mg | 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.
Latency to persistent sleep as measured by polysomnography
Measured: Hour +8
Secondary outcomes (22)
Subjective wake after sleep onset
Measured: Hour +8
Subjective total sleep time
Measured: Hour +8
Subjective assessment of sleep refreshment
Measured: Hour +8
Subjective assessment of sleep quality
Measured: Hour +8
Stanford Sleepiness Scale
Measured: Hour +13
Karolinska Sleep Diary-Sleep (KSD) Quality Index
Measured: Hour +8
KSD individual scores
Measured: Hour +8
Digit Symbol Substitution Test
Measured: Hour +8
Latency to REM sleep
Measured: Hour +8
Number of awakenings
Measured: Hour +8
Wake after sleep onset
Measured: Hour +8
Total wake time plus Stage 1 sleep
Measured: Hour +8
Total sleep time
Measured: Hour +8
Sleep efficiency
Measured: Hour +8
Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep
Measured: Hour +8
Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)
Measured: Hour +8
Vital signs
Measured: Hour +8
Adverse events
Measured: Hour +13
Sleep onset latency
Measured: Hour +8
Percent slow wave sleep (Stages 3&4 combined)
Measured: Hour +8
Subjective sleep latency
Measured: Hour +8
Subjective number of awakenings
Measured: Hour +8
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 startOct 2004
- Study completionNov 2004
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
- 309 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
- NCT00666770
- Sponsor's protocol ID
- A9451139
- 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, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance
- ClinicalTrials.gov ID
- NCT00666770
- Acronym / sponsor ID
- A9451139
- Conditions
- Transient Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Nov 2004 (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 effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gabapentin 250 mg | Experimental | Drug: Gabapentin |
| Gabapentin 500 mg | Experimental | Drug: Gabapentin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged >/= 18 years
- Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening
Key exclusion criteria (2 listed)
- Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
- Recreational drug use within past 30 days
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 250 mg oral capsule 30 minutes prior to bedtime | Drug | Gabapentin 250 mg |
| GabapentinGabapentin 500 mg oral capsule 30 minutes prior to bedtime | Drug | Gabapentin 500 mg |
| PlaceboMatched placebo 30 minutes prior to bedtime | Drug | Placebo |
Primary outcome
Latency to persistent sleep as measured by polysomnography
Time frame: Hour +8
22 secondary outcomes
Subjective wake after sleep onset
Time frame: Hour +8
Subjective total sleep time
Time frame: Hour +8
Subjective assessment of sleep refreshment
Time frame: Hour +8
Subjective assessment of sleep quality
Time frame: Hour +8
Stanford Sleepiness Scale
Time frame: Hour +13
Karolinska Sleep Diary-Sleep (KSD) Quality Index
Time frame: Hour +8
KSD individual scores
Time frame: Hour +8
Digit Symbol Substitution Test
Time frame: Hour +8
Latency to REM sleep
Time frame: Hour +8
Number of awakenings
Time frame: Hour +8
Wake after sleep onset
Time frame: Hour +8
Total wake time plus Stage 1 sleep
Time frame: Hour +8
Total sleep time
Time frame: Hour +8
Sleep efficiency
Time frame: Hour +8
Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep
Time frame: Hour +8
Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)
Time frame: Hour +8
Vital signs
Time frame: Hour +8
Adverse events
Time frame: Hour +13
Sleep onset latency
Time frame: Hour +8
Percent slow wave sleep (Stages 3&4 combined)
Time frame: Hour +8
Subjective sleep latency
Time frame: Hour +8
Subjective number of awakenings
Time frame: Hour +8
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
5 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 5 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 2 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 5 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?
Latency to persistent sleep as measured by polysomnography (time frame: Hour +8). 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.