Sleep DisordersPhase 4NCT01024192
Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA
A Phase 4 study testing ZOLPIDEM SL800750 in people with Sleep Disorders, run by Sanofi at 1 site in Mexico.
Trial summary
Primary Objective: To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice Secondary Objective: To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as needed basis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- ZOLPIDEM SL800750
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2009to Jul 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary insomnia diagnosis (difficulty for initiating sleep, or maintaining sleep to wake up to early in the morning, or to present a restless sleep) which causes clinically significant disturbances in the areas of social, work functioning or other important areas
Who cannot join
- Serious, severe and/or acute respiratory impairment
- Severe liver impairment
- Hypersensitivity to the formulation components or to some of its active metabolites
- Pregnant or breast-feeding women Patients with important associated disorders in SNC and specially psychotic disorders
- Patients with the probability of using alcoholic beverages concomitantly (as a precaution measure)
- Chronic use of benzodiazepines
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- Moreover, in order to follow the international regulations in terms of the use and handling of hypnotic compounds, and to guarantee the appropriate study performance, no patients with one or more of the following characteristics should be included:
- Patients who cannot comply to follow-up
- Patients who have any drug abuse problem
- Individuals who work changing night shifts or with pathological snoring
- Presence (or suspicion) of sleep apnea, periodical legs movements or restless legs syndrome
- 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
1 site in 1 country.
About this study
Official title: Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) Administered on as Needed Basis in Patients With Chronic insomNIA
Primary Objective:
To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice
Secondary Objective:
To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as needed basis.
- Conditions
- Sleep Disorders
- Being tested
- ZOLPIDEM SL800750
- 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.
ZOLPIDEM SL800750Drug
Pharmaceutical form: Zopidem 12.5 mg tablets
Route of administration: Oral
Dose regimen:One tablet at bed time and as needed (the patients choose which night they take the tablet without limit of number of nights)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Zolpidem 12.5mg tablet at bed time during 12 weeks Receives: Drug: ZOLPIDEM SL800750 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the Clinical Global Impression (CGI) score
Measured: At day 84 (visit 5)
Secondary outcomes (4)
Illness severity and average change during the study
Measured: At day 1 (baseline), day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)
Pittsburgh Sleep Quality Index (PSQI) score
Measured: At day 1 (baseline), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)
Patient satisfaction questionnaire
Measured: At day 84 (visit 5)
Safety evaluation via Adverse events reported
Measured: At day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionJul 2010
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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Affairs, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024192
- Sponsor's protocol ID
- ZOLPI_L_04134
- Status last verified
- Oct 2010
- First submitted
- 30 Nov 2009
- Last updated
- 5 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) Administered on as Needed Basis in Patients With Chronic insomNIA
- ClinicalTrials.gov ID
- NCT01024192
- Acronym / sponsor ID
- ZOLPI_L_04134
- Conditions
- Sleep Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Dec 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.
Primary Objective:
To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice
Secondary Objective:
To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as needed basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ZOLPIDEM SL800750Zolpidem 12.5mg tablet at bed time during 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary insomnia diagnosis (difficulty for initiating sleep, or maintaining sleep to wake up to early in the morning, or to present a restless sleep) which causes clinically significant disturbances in the areas of social, work functioning or other important areas
Key exclusion criteria (12 listed)
- Serious, severe and/or acute respiratory impairment
- Severe liver impairment
- Hypersensitivity to the formulation components or to some of its active metabolites
- Pregnant or breast-feeding women Patients with important associated disorders in SNC and specially psychotic disorders
- Patients with the probability of using alcoholic beverages concomitantly (as a precaution measure)
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 SL800750Pharmaceutical form: Zopidem 12.5 mg tablets Route of administration: Oral Dose regimen:One tablet at bed time and as needed (the patients choose which night they take the tablet without limit of number of nights) | Drug | 1 |
Primary outcome
Improvement of the Clinical Global Impression (CGI) score
Time frame: At day 84 (visit 5)
4 secondary outcomes
Illness severity and average change during the study
Time frame: At day 1 (baseline), day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)
Pittsburgh Sleep Quality Index (PSQI) score
Time frame: At day 1 (baseline), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)
Patient satisfaction questionnaire
Time frame: At day 84 (visit 5)
Safety evaluation via Adverse events reported
Time frame: At day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)
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 5 Oct 2010.
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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.
Medical Affairs study director
Sanofi
1 site 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 SL800750 in people with Sleep Disorders, run by Sanofi at 1 site in Mexico.
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 1 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 5 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
Improvement of the Clinical Global Impression (CGI) score (time frame: At day 84 (visit 5)). 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 5 Oct 2010.