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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014