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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00530556 |
Purpose
To assess the efficacy and safety of zolpidem at doses up to 10 mg compared to placebo in patients with insomnia associated with osteoarthritis
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Disorders |
Drug: zolpidem |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | Effect of Zolpidem vs Placebo on Insomnia and Daytime Function in Patients With Insomnia Associated With Osteoarthritis |
| Enrollment: | 132 |
| Study Start Date: | March 2003 |
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients that fail to complete at least 3 of 7 consecutive nights and days (day must follow night to be consecutive) on their Evening and Morning Questionnaires during the screening period and have not satisfied the following:
a Wake Time after Sleep Onset of greater than 1 hour, and/or having time to fall asleep (sleep latency) of 45 minutes or greater.
Contacts and Locations
More Information
| Study ID Numbers: | L_8445 |
| Study First Received: | September 14, 2007 |
| Last Updated: | September 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00530556 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Zolpidem Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Osteoarthritis Joint Diseases Physiological Effects of Drugs Nervous System Diseases Central Nervous System Depressants Sleep Disorders Rheumatic Diseases Pharmacologic Actions |
Signs and Symptoms Musculoskeletal Diseases Mental Disorders Therapeutic Uses Arthritis GABA Agonists Hypnotics and Sedatives Neurologic Manifestations GABA Agents Central Nervous System Agents |