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

Sleep Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024192
• Other study ID #: ZOLPI_L_04134
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2009
• Last updated: October 4, 2010
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: October 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Mexico	Sanofi-Aventis Administrative Office	Col. Coyoacan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of the Clinical Global Impression (CGI) score		At day 84 (visit 5)	No
Secondary	Illness severity and average change during the study		At day 1 (baseline), day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)	No
Secondary	Pittsburgh Sleep Quality Index (PSQI) score		At day 1 (baseline), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)	No
Secondary	Patient satisfaction questionnaire		At day 84 (visit 5)	No
Secondary	Safety evaluation via Adverse events reported		At day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)	Yes