Sleep Satisfaction and Psychomotor Performance of Adults (MORFEO CR)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01097382
First received: March 31, 2010
Last updated: July 16, 2012
Last verified: July 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Disorders |
Drug: ZOLPIDEM |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire) [ Time Frame: at Baseline, at V2 (26 +/- 2 days) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale) [ Time Frame: at Baseline, at V2 (26 +/- 2 days) ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | March 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AMBIEN CR
AMBIEN CR 12.5 mg once daily immediately before bedtime or in elderly/hepatically impaired patients: 6.25 mg once daily immediately before bedtime
|
Drug: ZOLPIDEM
Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097382
Locations
| Argentina | |
| Investigational Site Number 10 | |
| Buenos Aires, Argentina | |
| Investigational Site Number 1 | |
| C.a.b.a., Argentina | |
| Investigational Site Number 4 | |
| C.a.b.a., Argentina | |
| Investigational Site Number 6 | |
| C.a.b.a., Argentina | |
| Investigational Site Number 2 | |
| Capital Federal, Argentina, C1181ACH | |
| Investigational Site Number 3 | |
| La Plata, Argentina | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01097382 History of Changes |
| Other Study ID Numbers: | ZOLPI_L_04551, U1111-1116-9105 |
| Study First Received: | March 31, 2010 |
| Last Updated: | July 16, 2012 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Additional relevant MeSH terms:
|
Sleep Disorders Parasomnias Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Zolpidem Hypnotics and Sedatives Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013