Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00530556 |
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 |
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.
Study ID Numbers: | L_8445 |
Study First Received: | September 14, 2007 |
Last Updated: | September 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00530556 |
Health Authority: | United States: Food and Drug Administration |
Zolpidem Signs and Symptoms Musculoskeletal Diseases Mental Disorders Osteoarthritis |
Joint Diseases Arthritis Neurologic Manifestations Sleep Disorders Rheumatic Diseases |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses GABA Agonists Hypnotics and Sedatives Physiological Effects of Drugs |
Nervous System Diseases Central Nervous System Depressants GABA Agents Central Nervous System Agents Pharmacologic Actions |