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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01024192
First received: November 30, 2009
Last updated: October 4, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Sleep Disorders
 Drug: ZOLPIDEM SL800750
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) Administered on as Needed Basis in Patients With Chronic insomNIA

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Improvement of the Clinical Global Impression (CGI) score [ Time Frame: At day 84 (visit 5) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Patient satisfaction questionnaire [ Time Frame: At day 84 (visit 5) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 135
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Zolpidem 12.5mg tablet at bed time during 12 weeks
 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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024192

Locations
Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Affairs Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01024192     History of Changes
Other Study ID Numbers: ZOLPI_L_04134
Study First Received: November 30, 2009
Last Updated: October 4, 2010
Health Authority: Mexico: Ethics Committee

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Sleep Initiation and Maintenance Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Zolpidem
Hypnotics and Sedatives
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013