InsomniaPhase 4NCT00653562
Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography
A Phase 4 study testing zolpidem in people with Insomnia and Sleep Initiation and Maintenance Disorders, run by Astellas Pharma Inc at 4 sites in Japan.
Trial summary
To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Insomnia, Sleep Initiation and Maintenance Disorders
- What is being tested?
- zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 4 sitesJapan
- Study dates
- Nov 2006to Mar 2010
- Phase
- Phase 4
- 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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10
Who cannot join
- Patients with schizophrenia or manic-depressive illness
- Patients with insomnia caused by physical diseases
- Patients having a history of hypersensitivity to zolpidem
- Patients with attention-deficit hyperactivity disorder
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Kansai
Study site
Kantou
Study site
Kyusyu
Study site
Tōhoku
About this study
Official title: Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography
To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography
Read the detailed description
The study consists of two parts. All patients will receive placebo in one part and Zolpidem in the other part in a single blind manner. Efficacy will be measured with polysomnography .
- Being tested
- zolpidem
- Keywords
- polysomnography, zolpidem, Sleep disorders, adolescent
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zolpidemDrug
Also called Myslee
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients will receive placebo in one part and zolpidem in the other part Receives: Drug: zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep latency
Measured: 2 days
Secondary outcomes (4)
Total hours of sleep
Measured: 2 days
Frequency of intermediate awaking
Measured: 2 days
Time of intermediate awaking
Measured: 2 days
Patient impression
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startNov 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653562
- Sponsor's protocol ID
- 6199-JC-0002
- Status last verified
- Feb 2017
- First submitted
- 2 Apr 2008
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography
- ClinicalTrials.gov ID
- NCT00653562
- Acronym / sponsor ID
- 6199-JC-0002
- Keywords
- polysomnography, zolpidem, Sleep disorders, adolescent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 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.
To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography
Detailed description
The study consists of two parts. All patients will receive placebo in one part and Zolpidem in the other part in a single blind manner. Efficacy will be measured with polysomnography .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: zolpidemPatients will receive placebo in one part and zolpidem in the other part |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10
Key exclusion criteria (4 listed)
- Patients with schizophrenia or manic-depressive illness
- Patients with insomnia caused by physical diseases
- Patients having a history of hypersensitivity to zolpidem
- Patients with attention-deficit hyperactivity disorder
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 |
|---|---|---|
| zolpidemAlso: MysleeOral | Drug | 1 |
Primary outcome
Sleep latency
Time frame: 2 days
4 secondary outcomes
Total hours of sleep
Time frame: 2 days
Frequency of intermediate awaking
Time frame: 2 days
Time of intermediate awaking
Time frame: 2 days
Patient impression
Time frame: 2 days
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 17 Feb 2017.
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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.
Use Central Contact study chair
Astellas Pharma Inc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zolpidem in people with Insomnia and Sleep Initiation and Maintenance Disorders, run by Astellas Pharma Inc at 4 sites in Japan.
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 4 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Sleep latency (time frame: 2 days). 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 17 Feb 2017.