InsomniaPhase 3NCT00466193
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
A Phase 3 study testing zolpidem tartrate sublingual tablet in people with Insomnia, run by Transcept Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia
- What is being tested?
- zolpidem tartrate sublingual tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Nov 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults with history of sleeplessness
Who cannot join
- Allergic to investigational drug
- Any conditions and medications that may interfere with study drug evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Transcept Investigational Site
Durham, North Carolina, 27710
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Tablet in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night (MOTN)
The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.
- Conditions
- Insomnia
- Being tested
- zolpidem tartrate sublingual tablet, Placebo
- Keywords
- Insomnia
- 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.
zolpidem tartrate sublingual tabletDrug
Also called Intermezzo®
3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
PlaceboDrug
Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
| Study group | Role | What they receive |
|---|---|---|
| Zolpidem 3.5mg | Experimental | Not described Receives: Drug: zolpidem tartrate sublingual tablet |
| 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 Sleep Onset After Middle-of-the-Night Awakening at Baseline
Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?
Measured: Weeks -1 to 0
Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment
Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?
Measured: Weeks 1 to 4
Secondary outcomes (8)
Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline
Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?
Measured: Weeks -1 to 0
Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment
Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?
Measured: Weeks 1 to 4
Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.
Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?
Measured: Weeks -1 to 0
Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment
Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?
Measured: Weeks 1 to 4
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline
The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during the baseline period. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?
Measured: Weeks -1 to 0
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment
The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during double-blind treatment. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?
Measured: Weeks 1 to 4
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline
Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). During the baseline period, all participants received placebo.
Measured: Weeks -1 to 0
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment
Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). Values are from dosing nights during double-blind treatment.
Measured: Weeks 1 to 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transcept Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Krystal, MD, Principal investigator, Clinical Neurophysiology Training Program, Duke UniversityThomas Roth, PhD, Principal investigator, Sleep Disorders and Research Center, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466193
- Sponsor's protocol ID
- ZI-12
- Status last verified
- Feb 2012
- First submitted
- 24 Apr 2007
- Last updated
- 14 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Tablet in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night (MOTN)
- ClinicalTrials.gov ID
- NCT00466193
- Acronym / sponsor ID
- ZI-12
- Conditions
- Insomnia
- Keywords
- Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Transcept PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Posted 20 Jan 2012
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 the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zolpidem 3.5mg | Experimental | Drug: zolpidem tartrate sublingual tablet |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults with history of sleeplessness
Key exclusion criteria (2 listed)
- Allergic to investigational drug
- Any conditions and medications that may interfere with study drug evaluation
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 |
|---|---|---|
| zolpidem tartrate sublingual tabletAlso: Intermezzo®3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. | Drug | Zolpidem 3.5mg |
| PlaceboPlacebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. | Drug | Placebo |
Primary outcome
Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline
Time frame: Weeks -1 to 0
Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?
Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment
Time frame: Weeks 1 to 4
Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?
8 secondary outcomes
Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline
Time frame: Weeks -1 to 0
Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment
Time frame: Weeks 1 to 4
Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.
Time frame: Weeks -1 to 0
Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment
Time frame: Weeks 1 to 4
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline
Time frame: Weeks -1 to 0
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment
Time frame: Weeks 1 to 4
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline
Time frame: Weeks -1 to 0
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment
Time frame: Weeks 1 to 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew Krystal, MD principal investigator
Clinical Neurophysiology Training Program, Duke University
Thomas Roth, PhD principal investigator
Sleep Disorders and Research Center, Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zolpidem tartrate sublingual tablet in people with Insomnia, run by Transcept Pharmaceuticals at 1 site 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 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 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 20 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Sleep Onset After Middle-of-the-Night Awakening at Baseline (time frame: Weeks -1 to 0). 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 14 Feb 2012.