InsomniaPhase 4NCT00432198
Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
A Phase 4 study testing Zolpidem (Myslee®) in people with Insomnia, run by Astellas Pharma Inc at 7 sites in Japan.
Trial summary
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Zolpidem (Myslee®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 7 sitesJapan
- Study dates
- Feb 2007to Jan 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
- patients whose age at the time of obtaining consent is 12 years or over and 18 years or below
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
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chubu Region
Study site
Chugoku Region
Study site
Hokkaido Region
Study site
Kansai Region
Study site
Kanto Region
Study site
Kyushyu Region
Study site
Shikoku Region
About this study
Official title: Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial
- Conditions
- Insomnia
- Being tested
- Zolpidem (Myslee®), placebo
- Keywords
- Insomnia, Zolpidem, Adolescent
- 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 (Myslee®)Drug
Also called Myslee, FK199B
Oral
placeboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral Receives: Drug: Zolpidem (Myslee®) |
| 2 | Experimental | Oral Receives: Drug: Zolpidem (Myslee®) |
| 3 | Placebo comparator | Oral Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily sleep latency for double-blind period
Measured: 2 Weeks
Secondary outcomes (4)
Mean daily total hours of sleep
Measured: 2 Weeks
Mean daily frequency of intermediate awaking
Measured: 2 Weeks
Mean daily time of intermediate awaking
Measured: 2 Weeks
Impression of patient for double-blind period
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2010
- Study completionJan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 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
- NCT00432198
- Sponsor's protocol ID
- 6199-JC-0001
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2007
- 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
- Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia
- ClinicalTrials.gov ID
- NCT00432198
- Acronym / sponsor ID
- 6199-JC-0001
- Conditions
- Insomnia
- Keywords
- Insomnia, Zolpidem, Adolescent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Feb 2007 (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 investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Zolpidem (Myslee®)Oral |
| 2 | Experimental | Drug: Zolpidem (Myslee®)Oral |
| 3 | Placebo comparator | Drug: placeboOral |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10
- patients whose age at the time of obtaining consent is 12 years or over and 18 years or below
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 |
|---|---|---|
| Zolpidem (Myslee®)Also: Myslee, FK199BOral | Drug | 1, 2 |
| placeboOral | Drug | 3 |
Primary outcome
Mean daily sleep latency for double-blind period
Time frame: 2 Weeks
4 secondary outcomes
Mean daily total hours of sleep
Time frame: 2 Weeks
Mean daily frequency of intermediate awaking
Time frame: 2 Weeks
Mean daily time of intermediate awaking
Time frame: 2 Weeks
Impression of patient for double-blind period
Time frame: 2 Weeks
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
7 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 (Myslee®) in people with Insomnia, run by Astellas Pharma Inc at 7 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 2 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 7 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. 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 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?
Mean daily sleep latency for double-blind period (time frame: 2 Weeks). 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.