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Sleep Satisfaction and Psychomotor Performance of Adults (MORFEO CR)

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ClinicalTrials.gov Identifier: NCT01097382
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE March 31, 2010
First Posted Date  ICMJE April 1, 2010
Last Update Posted Date July 17, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2010)
Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire) [ Time Frame: at Baseline, at V2 (26 +/- 2 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01097382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2010)
Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale) [ Time Frame: at Baseline, at V2 (26 +/- 2 days) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Satisfaction and Psychomotor Performance of Adults
Official Title  ICMJE 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
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sleep Disorders
Intervention  ICMJE Drug: ZOLPIDEM
Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2011)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2010)
77
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01097382
Other Study ID Numbers  ICMJE ZOLPI_L_04551
U1111-1116-9105 ( Other Identifier: UTN )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date July 2012

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