Sleep Satisfaction and Psychomotor Performance of Adults | NCT01097382

Studies
Sleep Satisfaction and Psychomotor Performance of Adults

NCT01097382

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jul 17, 2012Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Sleep Disorders

Interventions

ZOLPIDEM

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1116-9105	Other Identifier	UTN

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Mar 31, 2010

First Submission Date that Met QC Criteria

Mar 31, 2010

First Posted Date

Apr 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2012

Last Update Posted Date

Jul 17, 2012Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ZOLPIDEM	Drug	Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily	AMBIEN CR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)		at Baseline, at V2 (26 +/- 2 days)

Secondary Outcomes

Measure	Description	Time Frame
Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)		at Baseline, at V2 (26 +/- 2 days)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 10		Buenos Aires			Argentina
Investigational Site Number 1

Condition Browse Module

MeSH Terms

ID	Term
D012893	Sleep Wake Disorders

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds