Sleep Initiation and Maintenance DisordersPhase 3NCT00283946
A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia
A Phase 3 study testing Zolpidem MR and Zolpidem in people with Sleep Initiation and Maintenance Disorders and Sleep Disorders, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Sleep Disorders
- What is being tested?
- Zolpidem MR and Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 876 participants
- Where
- 8 sitesJapan
- Study dates
- Feb 2006to Nov 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of nonorganic insomnia.
- Must be able to swallow tablets
Who cannot join
- Allergic reactions to zolpidem (Myslee)
- Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chubu Region
Study site
Chugoku Region
Study site
Hokkaido Region
Study site
Kansai Region
Study site
Kanto Region
Study site
Kyushu Region
Study site
Shikoku Region
Study site
Tohoku Region
About this study
Official title: FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia -
The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug
- Being tested
- Zolpidem MR, Zolpidem
- Keywords
- zolpidem, sleep initiation and maintenance disorders Hypnotics and sedatives, double-blind study, comparative study
- 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.
Zolpidem MRDrug
Oral
ZolpidemDrug
Also called Myslee
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Zolpidem MR |
| 2 | Active comparator | Not described Receives: Drug: Zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean wake time after sleep onset during the double-blind period
Measured: 2 Weeks
Secondary outcomes (5)
Mean total sleep time during the double-blind period
Measured: 2 Weeks
Mean number of nightly awakenings during the double-blind period
Measured: 2 Weeks
Mean sleep latency during the double-blind period
Measured: 2 Weeks
Patient impression during the double-blind period
Measured: 2 Weeks
Safety
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 posted31 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionNov 2007
- Study completionNov 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 876 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283946
- Sponsor's protocol ID
- 6199-CL-0007
- Status last verified
- Aug 2014
- First submitted
- 30 Jan 2006
- 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, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia -
- ClinicalTrials.gov ID
- NCT00283946
- Acronym / sponsor ID
- 6199-CL-0007
- Keywords
- zolpidem, sleep initiation and maintenance disorders Hypnotics and sedatives, double-blind study, comparative study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 876 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 31 Jan 2006 (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 investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Zolpidem MR |
| 2 | Active comparator | Drug: Zolpidem |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of nonorganic insomnia.
- Must be able to swallow tablets
Key exclusion criteria (2 listed)
- Allergic reactions to zolpidem (Myslee)
- Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.
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 MROral | Drug | 1 |
| ZolpidemAlso: MysleeOral | Drug | 2 |
Primary outcome
Mean wake time after sleep onset during the double-blind period
Time frame: 2 Weeks
5 secondary outcomes
Mean total sleep time during the double-blind period
Time frame: 2 Weeks
Mean number of nightly awakenings during the double-blind period
Time frame: 2 Weeks
Mean sleep latency during the double-blind period
Time frame: 2 Weeks
Patient impression during the double-blind period
Time frame: 2 Weeks
Safety
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 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.
Central Contact study chair
Astellas Pharma Inc
8 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 Zolpidem MR and Zolpidem in people with Sleep Initiation and Maintenance Disorders and Sleep Disorders, run by Astellas Pharma Inc at 8 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 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 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 8 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?
Mean wake time after sleep onset during the 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 20 Aug 2014.