Sleep Satisfaction and Psychomotor Performance of Adults

NCT01097382 | Completed Phase 4

• 2 other identifiers: ZOLPI_L_04551U1111-1116-9105
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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

Conditions

Sleep Disorders

Outcome Measures

Primary Outcomes (1)

• Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)

  at Baseline, at V2 (26 +/- 2 days)

Secondary Outcomes (1)

• Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)

  at Baseline, at V2 (26 +/- 2 days)

Study Arms (1)

AMBIEN CR

EXPERIMENTAL

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

Interventions

ZOLPIDEM DRUG

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

AMBIEN CR

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (6)

Investigational Site Number 10

Buenos Aires, Argentina

Location

Investigational Site Number 1

C.a.b.a., Argentina

Location

Investigational Site Number 4

C.a.b.a., Argentina

Location

Investigational Site Number 6

C.a.b.a., Argentina

Location

Investigational Site Number 2

Capital Federal, C1181ACH, Argentina

Location

Investigational Site Number 3

La Plata, Argentina

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 1, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

AR (6)