Back to resultsSleep Satisfaction and Psychomotor Performance of Adults (MORFEO CR)
Primary Purpose
Sleep Disorders
Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
ZOLPIDEM
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disorders
Eligibility 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.
Sites / Locations
- Investigational Site Number 10
- Investigational Site Number 1
- Investigational Site Number 4
- Investigational Site Number 6
- Investigational Site Number 2
- Investigational Site Number 3
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AMBIEN CR
Arm Description
AMBIEN CR 12.5 mg once daily immediately before bedtime or in elderly/hepatically impaired patients: 6.25 mg once daily immediately before bedtime
Outcomes
Primary Outcome Measures
Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)
Secondary Outcome Measures
Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01097382
Brief Title
Sleep Satisfaction and Psychomotor Performance of Adults
Acronym
MORFEO CR
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMBIEN CR
Arm Type
Experimental
Arm Description
AMBIEN CR 12.5 mg once daily immediately before bedtime or in elderly/hepatically impaired patients: 6.25 mg once daily immediately before bedtime
Intervention Type
Drug
Intervention Name(s)
ZOLPIDEM
Intervention Description
Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily
Primary Outcome Measure Information:
Title
Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)
Time Frame
at Baseline, at V2 (26 +/- 2 days)
Secondary Outcome Measure Information:
Title
Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)
Time Frame
at Baseline, at V2 (26 +/- 2 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 10
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site Number 1
City
C.a.b.a.
Country
Argentina
Facility Name
Investigational Site Number 4
City
C.a.b.a.
Country
Argentina
Facility Name
Investigational Site Number 6
City
C.a.b.a.
Country
Argentina
Facility Name
Investigational Site Number 2
City
Capital Federal
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Investigational Site Number 3
City
La Plata
Country
Argentina
12. IPD Sharing Statement
Learn more about this trial
Sleep Satisfaction and Psychomotor Performance of Adults
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