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Sleep Satisfaction and Psychomotor Performance of Adults (MORFEO CR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01097382
First received: March 31, 2010
Last updated: July 16, 2012
Last verified: July 2012
History of Changes

March 31, 2010
July 16, 2012
March 2010
April 2011   (final data collection date for primary outcome measure)
Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire) [ Time Frame: at Baseline, at V2 (26 +/- 2 days) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01097382 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Sleep Satisfaction and Psychomotor Performance of Adults
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
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sleep Disorders
Drug: ZOLPIDEM
Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily
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
Intervention: Drug: ZOLPIDEM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01097382
ZOLPI_L_04551, U1111-1116-9105
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP