Clinical trial NCT01024192: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Disorders
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Improvement of the Clinical Global Impression (CGI) score
timeFrame: At day 84 (visit 5)
Secondary outcomes:
measure: Illness severity and average change during the study
timeFrame: At day 1 (baseline), day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)
measure: Pittsburgh Sleep Quality Index (PSQI) score
timeFrame: At day 1 (baseline), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)
measure: Patient satisfaction questionnaire
timeFrame: At day 84 (visit 5)
measure: Safety evaluation via Adverse events reported
timeFrame: At day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)
Other outcomes:
Locations:
city: Col. Coyoacan
country: Mexico
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Medical Affairs
role: STUDY_DIRECTOR
References: