Sleep Initiation and Maintenance DisordersPhase 3NCT00999219
A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia
A Phase 3 study testing FK199B and Zolpidem in people with Sleep Initiation and Maintenance Disorders, run by Astellas Pharma Inc at 7 sites in Japan.
Trial summary
This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- FK199B and Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 7 sitesJapan
- Study dates
- Mar 2006to Jul 2007
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is diagnosed as a primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Patients complaining of insomnia continuously for 4 weeks or longer
- Patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening
- Patient on most occasions sleeps for a total of ≥3 and <6.5 hours over the 4 week period prior to initial screening
- Patient's usual wake time after sleep onset in a single night is ≥45 minutes per night for the 4 week period prior to initial screening
- Patients have a body weight of ≥45 kg and ≤85 kg, a BMI of ≥18.5 and <30
Who cannot join
- Patients with schizophrenia or manic-depressive psychosis
- Patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic
- Patients with circadian rhythm sleep disorder
- Patient works night shifts
- Patients with alcoholic sleep disorder
- Patients with alcohol or drug dependence or a history of these
Show all 12Show fewer
- Patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs
- Patients with sleep apnea syndrome
- Patients with restless legs syndrome or periodic limb movement disorder
- Patients with epileptic insomnia
- Patients smoke on average 40 or more cigarettes a day
- Patients who had received psychotropic drugs other than hypnotics (including anxiolytic or antidepressant drugs for hypnotic effect) within a 4 week period prior to the initial screening
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chūbu
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyushu
Study site
Shikoku
Study site
Tōhoku
About this study
Official title: FK199B (Zolpidem MR Tablet) Phase III Clinical Study - A Double-Blind, Crossover, Comparative Polysomnographic Study Using Zolpidem (Myslee®) as a Positive Control in Patients With Insomnia, Excluding Patients With Schizophrenia or Manic-Depressive Psychosis
This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis.
- Being tested
- FK199B, Zolpidem
- Keywords
- FK199B, Zolpidem
- 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.
FK199BDrug
Also called Zolpidem MR Tablet
oral
ZolpidemDrug
Also called Myslee
oral
| Study group | Role | What they receive |
|---|---|---|
| FK199B-first group | Experimental | Not described Receives: Drug: FK199B; Drug: Zolpidem |
| Zolpidem-first group | Experimental | Not described Receives: Drug: FK199B; Drug: Zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)
Measured: 8 hours
Secondary outcomes (3)
Mean sleep parameters estimated from polysomnography recording
Measured: 8 hours
Sleep parameters estimated from sleep questionnaire
Measured: After each night of sleep during the study period
Patient impression from sleep questionnaire
Measured: After each night of sleep during the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startMar 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 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
- NCT00999219
- Sponsor's protocol ID
- 6199-CL-0006
- Status last verified
- Aug 2014
- First submitted
- 13 Oct 2009
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FK199B (Zolpidem MR Tablet) Phase III Clinical Study - A Double-Blind, Crossover, Comparative Polysomnographic Study Using Zolpidem (Myslee®) as a Positive Control in Patients With Insomnia, Excluding Patients With Schizophrenia or Manic-Depressive Psychosis
- ClinicalTrials.gov ID
- NCT00999219
- Acronym / sponsor ID
- 6199-CL-0006
- Keywords
- FK199B, Zolpidem
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 21 Oct 2009 (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.
This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FK199B-first group | Experimental | Drug: FK199B, Drug: Zolpidem |
| Zolpidem-first group | Experimental | Drug: FK199B, Drug: Zolpidem |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is diagnosed as a primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Patients complaining of insomnia continuously for 4 weeks or longer
- Patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening
- Patient on most occasions sleeps for a total of ≥3 and <6.5 hours over the 4 week period prior to initial screening
- Patient's usual wake time after sleep onset in a single night is ≥45 minutes per night for the 4 week period prior to initial screening
Key exclusion criteria (12 listed)
- Patients with schizophrenia or manic-depressive psychosis
- Patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic
- Patients with circadian rhythm sleep disorder
- Patient works night shifts
- Patients with alcoholic sleep 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 |
|---|---|---|
| FK199BAlso: Zolpidem MR Tabletoral | Drug | FK199B-first group, Zolpidem-first group |
| ZolpidemAlso: Mysleeoral | Drug | FK199B-first group, Zolpidem-first group |
Primary outcome
Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)
Time frame: 8 hours
3 secondary outcomes
Mean sleep parameters estimated from polysomnography recording
Time frame: 8 hours
Sleep parameters estimated from sleep questionnaire
Time frame: After each night of sleep during the study period
Patient impression from sleep questionnaire
Time frame: After each night of sleep during the study period
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 20 Aug 2014.
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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 3 study testing FK199B and Zolpidem in people with Sleep Initiation and Maintenance Disorders, 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 6 inclusion and 12 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 20 Aug 2014. 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. 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?
Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings) (time frame: 8 hours). 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 20 Aug 2014.