Sleep Initiation and Maintenance DisordersPhase 4NCT01181232
A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients
A Phase 4 study testing Zolpidem MR and Zolpidem IR in people with Sleep Initiation and Maintenance Disorders and Primary Insomnia, run by Astellas Pharma Inc at 2 sites in Taiwan.
Trial summary
The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Primary Insomnia
- What is being tested?
- Zolpidem MR and Zolpidem IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesTaiwan
- Study dates
- Oct 2009to Apr 2011
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
- Written informed consent has been obtained
Who cannot join
- Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome
- Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem
- Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)
- Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study
- Patients who are pregnant, lactating or intend to become pregnant during the study period
- Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study
- Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
- Participation in any clinical trial within 1 month prior to randomization
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Active Control, Parallel Study to Evaluate the Efficacy and Safety of Zolpidem MR (Stilnox CR) Versus Zolpidem (Stilnox) in Patients With Primary Insomnia
The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.
- Being tested
- Zolpidem MR, Zolpidem IR
- Keywords
- insomnia, 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.
Zolpidem MRDrug
Also called Stilnox CR, Ambient CR
oral
Zolpidem IRDrug
Also called Stilnox
oral
| Study group | Role | What they receive |
|---|---|---|
| MR low-dose group | Experimental | Not described Receives: Drug: Zolpidem MR |
| MR high-dose group | Experimental | Not described Receives: Drug: Zolpidem MR |
| IR group | Active comparator | Not described Receives: Drug: Zolpidem IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rest/activity cycles measured by Actigraphy
Measured: For 2 weeks (Day 0, Day 7, Day 14)
Total score of Pittsburgh Sleep Quality Index (PSQI)
Measured: For 2 weeks (Day 0, Day 7, Day 14)
Secondary outcomes (7)
Physician's clinical global impression (CGI)
Measured: For 2 weeks (Day 0, Day 7, Day 14)
Patient's global impression (PGI)
Measured: For 2 weeks (Day 0, Day 7, Day 14)
Sleep latency as derived from sleep diary
Measured: For 2 weeks (Day 0, Day 7, Day 14)
Number of awakenings as derived from sleep diary
Measured: For 2 weeks (Day 0, Day 7, Day 14)
Total sleep time as derived from sleep diary
Measured: For 2 weeks (Day 0, Day 7, Day 14)
Wake time after sleep onset as derived from sleep diary
Measured: For 2 weeks (Day 0, Day 7, Day 14)
Day time function as assessed by Epworth Sleepiness Scale (ESS)
Measured: For 2 weeks (Day 0, Day 7, Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionApr 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181232
- Sponsor's protocol ID
- STCR-0901-TW
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2010
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active Control, Parallel Study to Evaluate the Efficacy and Safety of Zolpidem MR (Stilnox CR) Versus Zolpidem (Stilnox) in Patients With Primary Insomnia
- ClinicalTrials.gov ID
- NCT01181232
- Acronym / sponsor ID
- STCR-0901-TW
- Keywords
- insomnia, zolpidem
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Aug 2010 (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 zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MR low-dose group | Experimental | Drug: Zolpidem MR |
| MR high-dose group | Experimental | Drug: Zolpidem MR |
| IR group | Active comparator | Drug: Zolpidem IR |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
- Written informed consent has been obtained
Key exclusion criteria (8 listed)
- Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome
- Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem
- Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)
- Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study
- Patients who are pregnant, lactating or intend to become pregnant during the study period
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 MRAlso: Stilnox CR, Ambient CRoral | Drug | MR high-dose group, MR low-dose group |
| Zolpidem IRAlso: Stilnoxoral | Drug | IR group |
Primary outcome
Rest/activity cycles measured by Actigraphy
Time frame: For 2 weeks (Day 0, Day 7, Day 14)
Total score of Pittsburgh Sleep Quality Index (PSQI)
Time frame: For 2 weeks (Day 0, Day 7, Day 14)
7 secondary outcomes
Physician's clinical global impression (CGI)
Time frame: For 2 weeks (Day 0, Day 7, Day 14)
Patient's global impression (PGI)
Time frame: For 2 weeks (Day 0, Day 7, Day 14)
Sleep latency as derived from sleep diary
Time frame: For 2 weeks (Day 0, Day 7, Day 14)
Number of awakenings as derived from sleep diary
Time frame: For 2 weeks (Day 0, Day 7, Day 14)
Total sleep time as derived from sleep diary
Time frame: For 2 weeks (Day 0, Day 7, Day 14)
Wake time after sleep onset as derived from sleep diary
Time frame: For 2 weeks (Day 0, Day 7, Day 14)
Day time function as assessed by Epworth Sleepiness Scale (ESS)
Time frame: For 2 weeks (Day 0, Day 7, Day 14)
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 10 Sep 2014.
Related trials for Sleep Initiation and Maintenance Disorders
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
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
2 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 MR and Zolpidem IR in people with Sleep Initiation and Maintenance Disorders and Primary Insomnia, run by Astellas Pharma Inc at 2 sites in Taiwan.
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 8 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 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Rest/activity cycles measured by Actigraphy (time frame: For 2 weeks (Day 0, Day 7, Day 14)). 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 10 Sep 2014.