Sleep DisordersPhase 4MORFEO CRNCT01097382
Sleep Satisfaction and Psychomotor Performance of Adults
A Phase 4 study testing ZOLPIDEM in people with Sleep Disorders, run by Sanofi at 6 sites in Argentina.
Trial summary
Primary Objective: To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration Secondary Objective: To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- ZOLPIDEM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesArgentina
- Study dates
- Mar 2010to 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients consulting Psychiatrists (private or hospital) -whatever the reason for consulting- who present with chronic primary insomnia from the DSM IV (Diagnostic and Statistical Manual - Revision 4).
- Accepting to participate in the study and signing informed consent
Who cannot join
- Pregnancy or breastfeeding.
- Current severe neuropsychiatric disorder (i.e. psychosis, obsessive compulsive disorder, major depression, dementia of Alzheimer or vascular type) according to DSM IV criteria.
- History of substance abuse or dependence (including alcohol) within the past year.
- Hypersensitivity to zolpidem or its excipients.
- Severe hepatic insufficiency
- Severe and/or acute respiratory insufficiency
Show all 10Show fewer
- Myasthenia gravis.
- OTC (Over The Counter) sleep remedies or prescription sleep medications within 2 weeks or 5 half-life before screening.
- Severe medical illness.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Argentina6 sites
Investigational Site Number 10
Buenos Aires
Investigational Site Number 1
C.a.b.a.
Investigational Site Number 4
C.a.b.a.
Investigational Site Number 6
C.a.b.a.
Investigational Site Number 2
Capital Federal, C1181ACH
Investigational Site Number 3
La Plata
About this study
Official title: National, Multicenter, Open Label, Phase IV, Before-after Design Study, in Adult Patients With Primary Insomnia to Evaluate Sleep Satisfaction and Psychomotor Performance After 1 Month of Treatment With Zolpidem CR (Ambien®CR) in 6 Sites in Argentina
Primary Objective:
To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration
Secondary Objective:
To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration
- Conditions
- Sleep Disorders
- Being tested
- ZOLPIDEM
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZOLPIDEMDrug
Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily
| Study group | Role | What they receive |
|---|---|---|
| AMBIEN CR | Experimental | AMBIEN CR 12.5 mg once daily immediately before bedtime or in elderly/hepatically impaired patients: 6.25 mg once daily immediately before bedtime Receives: Drug: ZOLPIDEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)
Measured: at Baseline, at V2 (26 +/- 2 days)
Secondary outcomes (1)
Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)
Measured: at Baseline, at V2 (26 +/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startMar 2010
- 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 DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097382
- Sponsor's protocol ID
- ZOLPI_L_04551
- Other IDs
- U1111-1116-9105
- Acronym
- MORFEO CR
- Status last verified
- Jul 2012
- First submitted
- 31 Mar 2010
- Last updated
- 17 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicenter, Open Label, Phase IV, Before-after Design Study, in Adult Patients With Primary Insomnia to Evaluate Sleep Satisfaction and Psychomotor Performance After 1 Month of Treatment With Zolpidem CR (Ambien®CR) in 6 Sites in Argentina
- ClinicalTrials.gov ID
- NCT01097382
- Acronym / sponsor ID
- MORFEO CR / ZOLPI_L_04551
- Conditions
- Sleep Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 1 Apr 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.
Primary Objective:
To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration
Secondary Objective:
To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMBIEN CR | Experimental | Drug: ZOLPIDEMAMBIEN CR 12.5 mg once daily immediately before bedtime or in elderly/hepatically impaired patients: 6.25 mg once daily immediately before bedtime |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients consulting Psychiatrists (private or hospital) -whatever the reason for consulting- who present with chronic primary insomnia from the DSM IV (Diagnostic and Statistical Manual - Revision 4).
- Accepting to participate in the study and signing informed consent
Key exclusion criteria (10 listed)
- Pregnancy or breastfeeding.
- Current severe neuropsychiatric disorder (i.e. psychosis, obsessive compulsive disorder, major depression, dementia of Alzheimer or vascular type) according to DSM IV criteria.
- History of substance abuse or dependence (including alcohol) within the past year.
- Hypersensitivity to zolpidem or its excipients.
- Severe hepatic insufficiency
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 |
|---|---|---|
| ZOLPIDEMPharmaceutical form: tablet Route of administration: oral Dose regimen: once daily | Drug | AMBIEN CR |
Primary outcome
Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)
Time frame: at Baseline, at V2 (26 +/- 2 days)
1 secondary outcome
Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)
Time frame: at Baseline, at V2 (26 +/- 2 days)
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 Jul 2012.
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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.
Clinical Sciences & Operations study director
Sanofi
6 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 in people with Sleep Disorders, run by Sanofi at 6 sites in Argentina.
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 10 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 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Argentina. 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?
Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire) (time frame: at Baseline, at V2 (26 +/- 2 days)). 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 Jul 2012.