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

NCT01024192 | Completed Phase 4

• 1 other identifier: ZOLPI_L_04134
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders

Outcome Measures

Primary Outcomes (1)

• Improvement of the Clinical Global Impression (CGI) score

  At day 84 (visit 5)

Secondary Outcomes (4)

• 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)

• Pittsburgh Sleep Quality Index (PSQI) score

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

• Patient satisfaction questionnaire

  At day 84 (visit 5)

• Safety evaluation via Adverse events reported

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

Study Arms (1)

1

EXPERIMENTAL

Zolpidem 12.5mg tablet at bed time during 12 weeks

Drug: ZOLPIDEM SL800750

Interventions

ZOLPIDEM SL800750 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)

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Col. Coyoacan, Mexico

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Affairs

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 5, 2010

Record last verified: 2010-10

Locations

ME (1)