InsomniaPhase 4STEPNCT00359229
Stilnox Treatment in Elderly Patients With Insomnia
A Phase 4 study testing Zolpidem in people with Insomnia, run by Sanofi.
Trial summary
Primary objective: 1. To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China Secondary objectives: 1. To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China. 2. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Zolpidem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Sep 2007
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Primary out-patient insomniac patient defined by DSM-IV criteria
- Insomnia history lasted at least 3 months , this history must include a self-reported usual sleep latency of 30 minutes or more and either 3 or more awakenings per night on average or a usual total sleep time of ≤6.5 hours
Who cannot join
- Usage of hypnotics within the previous 1-3 weeks before inclusion depending on the half-life of the hypnotics that would affect the study effect
- Concomitant usage of other hypnotics (benzodiazepines and Non-benzodiazepines) during the course if the study.
- Concomitant usage of the following Central Nervous System active medicine : antipsychotics , antidepressants ,anxiolytics, lithium and other psychotropic drugs.
- The score of Hamilton Depression Rating Scale (HAMD-24 ) more than 17.
- The score of Hamilton Anxiety Rating Scale (HAMA-14 ) more than 14.
- Patients having known hypersensitivity to Stilnox or any of the ingredients in the products
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- Patient with severe respiratory insufficiency
- Patients suffering from sleep apnoea syndrome
- Patients with known severe hepatic (risk of encephalopathy) and /or renal insufficiency, or other severe organ diseases
- Patients suffering from severe myasthenia gravis
- Patients with the previous history of drug abuse, drug dependence and drug addiction
- Any other disease state or major psychiatric condition that might affect study result
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: A Multicentre Prospective, Open Label ,3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China
Primary objective:
- To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China
Secondary objectives:
- To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China.
- To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China
- Conditions
- Insomnia
- Being tested
- 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.
ZolpidemDrug
Administration of Zolpidem 5mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | For 3 weeks Receives: Drug: Zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI) score
Measured: At 1 week versus baseline
Secondary outcomes (6)
Pittsburgh Sleep Quality Index score
Measured: At 3 weeks versus baseline
Subject sleeping efficacy variable
Measured: At 1 week and 3 weeks versus baseline
Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score
Measured: At 3 weeks versus baseline
Adverse events (AE) and Serious adverse events (SAE) reports
Measured: Throughout the study period
General Lab tests including hepatic and renal function
Measured: At 3 weeks versus baseline
Vital signs
Measured: At 1 week and 3 weeks versus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2007
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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bruno Jolain, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359229
- Sponsor's protocol ID
- ZOLPI_L_01540
- Acronym
- STEP
- Status last verified
- Sep 2009
- First submitted
- 31 Jul 2006
- Last updated
- 15 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective, Open Label ,3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China
- ClinicalTrials.gov ID
- NCT00359229
- Acronym / sponsor ID
- STEP / ZOLPI_L_01540
- Conditions
- Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Sep 2007 (actual)
- First posted
- 1 Aug 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.
Primary objective:
- To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China
Secondary objectives:
- To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China.
- To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ZolpidemFor 3 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Primary out-patient insomniac patient defined by DSM-IV criteria
- Insomnia history lasted at least 3 months , this history must include a self-reported usual sleep latency of 30 minutes or more and either 3 or more awakenings per night on average or a usual total sleep time of ≤6.5 hours
Key exclusion criteria (13 listed)
- Usage of hypnotics within the previous 1-3 weeks before inclusion depending on the half-life of the hypnotics that would affect the study effect
- Concomitant usage of other hypnotics (benzodiazepines and Non-benzodiazepines) during the course if the study.
- Concomitant usage of the following Central Nervous System active medicine : antipsychotics , antidepressants ,anxiolytics, lithium and other psychotropic drugs.
- The score of Hamilton Depression Rating Scale (HAMD-24 ) more than 17.
- The score of Hamilton Anxiety Rating Scale (HAMA-14 ) more than 14.
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 |
|---|---|---|
| ZolpidemAdministration of Zolpidem 5mg | Drug | 1 |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI) score
Time frame: At 1 week versus baseline
6 secondary outcomes
Pittsburgh Sleep Quality Index score
Time frame: At 3 weeks versus baseline
Subject sleeping efficacy variable
Time frame: At 1 week and 3 weeks versus baseline
Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) score
Time frame: At 3 weeks versus baseline
Adverse events (AE) and Serious adverse events (SAE) reports
Time frame: Throughout the study period
General Lab tests including hepatic and renal function
Time frame: At 3 weeks versus baseline
Vital signs
Time frame: At 1 week and 3 weeks versus baseline
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 15 Sep 2009.
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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.
Bruno Jolain study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zolpidem in people with Insomnia, run by Sanofi.
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 13 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 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Pittsburgh Sleep Quality Index (PSQI) score (time frame: At 1 week versus baseline). 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 15 Sep 2009.