Sleep Satisfaction and Psychomotor Performance of Adults

Sleep Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097382
• Other study ID #: ZOLPI_L_04551
• Secondary ID: U1111-1116-9105
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2010
• Last updated: July 16, 2012
• Start date: March 2010
• Est. completion date: April 2011

Study information

• Verified date: July 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders

Intervention

Drug:
• ZOLPIDEM
Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily

Locations

Country	Name	City	State
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	Investigational Site Number 3	La Plata

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)		at Baseline, at V2 (26 +/- 2 days)	No
Secondary	Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)		at Baseline, at V2 (26 +/- 2 days)	No