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

Primary Purpose

Sleep Disorders

Status

Completed

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

ZOLPIDEM SL800750

About this trial

This is an interventional treatment trial for Sleep Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Zolpidem 12.5mg tablet at bed time during 12 weeks

Outcomes

Primary Outcome Measures

Improvement of the Clinical Global Impression (CGI) score

Secondary Outcome Measures

Illness severity and average change during the study

Pittsburgh Sleep Quality Index (PSQI) score

Patient satisfaction questionnaire

Safety evaluation via Adverse events reported

Full Information

NCT ID

NCT01024192

First Posted

November 30, 2009

Last Updated

October 4, 2010

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01024192

Brief Title

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

Official Title

Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) Administered on as Needed Basis in Patients With Chronic insomNIA

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

135 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Zolpidem 12.5mg tablet at bed time during 12 weeks

Intervention Type

Drug

Intervention Name(s)

ZOLPIDEM SL800750

Intervention Description

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)

Primary Outcome Measure Information:

Title

Improvement of the Clinical Global Impression (CGI) score

Time Frame

At day 84 (visit 5)

Secondary Outcome Measure Information:

Title

Illness severity and average change during the study

Time Frame

At day 1 (baseline), day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)

Title

Pittsburgh Sleep Quality Index (PSQI) score

Time Frame

At day 1 (baseline), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)

Title

Patient satisfaction questionnaire

Time Frame

At day 84 (visit 5)

Title

Safety evaluation via Adverse events reported

Time Frame

At day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Affairs

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Col. Coyoacan

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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