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Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA

NCT ID: NCT01024192

Last Updated: 2010-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-07-31

Brief Summary

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Primary Objective:

To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice

Secondary Objective:

To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as needed basis.

Detailed Description

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Conditions

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Sleep Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Zolpidem 12.5mg tablet at bed time during 12 weeks

Group Type EXPERIMENTAL

ZOLPIDEM SL800750

Intervention Type DRUG

Pharmaceutical form: Zopidem 12.5 mg tablets

Route of administration: Oral

Dose regimen:One tablet at bed time and as needed (the patients choose which night they take the tablet without limit of number of nights)

Interventions

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ZOLPIDEM SL800750

Pharmaceutical form: Zopidem 12.5 mg tablets

Route of administration: Oral

Dose regimen:One tablet at bed time and as needed (the patients choose which night they take the tablet without limit of number of nights)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Primary insomnia diagnosis (difficulty for initiating sleep, or maintaining sleep to wake up to early in the morning, or to present a restless sleep) which causes clinically significant disturbances in the areas of social, work functioning or other important areas

Exclusion Criteria

* Serious, severe and/or acute respiratory impairment
* Severe liver impairment
* Hypersensitivity to the formulation components or to some of its active metabolites
* Pregnant or breast-feeding women Patients with important associated disorders in SNC and specially psychotic disorders
* Patients with the probability of using alcoholic beverages concomitantly (as a precaution measure)
* Chronic use of benzodiazepines

Moreover, in order to follow the international regulations in terms of the use and handling of hypnotic compounds, and to guarantee the appropriate study performance, no patients with one or more of the following characteristics should be included:

* Patients who cannot comply to follow-up
* Patients who have any drug abuse problem
* Individuals who work changing night shifts or with pathological snoring
* Presence (or suspicion) of sleep apnea, periodical legs movements or restless legs syndrome

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Medical Affairs

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Col. Coyoacan, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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ZOLPI_L_04134

Identifier Type: -

Identifier Source: org_study_id