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

NCT01024192 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2010-10-05

No results posted yet for this study

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.

Conditions

  • Sleep Disorders

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Medical Affairs · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Mexico

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024192 on ClinicalTrials.gov