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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00561574 |
The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of Org 50081 to investigate the safety and tolerability of long-term treatment with Org 50081 in elderly patients.
Condition | Intervention | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorder; Elderly Mental Disorder Dyssomnias Sleep Disorders Sleep Disorder, Intrinsic |
Drug: Org 50081 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | A Randomized Long-Term Safety Study of Org 50081 in Elderly Outpatients With Chronic Primary Insomnia Examining the Effects of 1.5 mg or 3.0 mg of Org 50081 |
Estimated Enrollment: | 250 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Org 50081-2: Experimental
One tablet daily
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Drug: Org 50081
One tablet daily
|
Org 50081-1: Experimental
One tablet daily
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Drug: Org 50081
One tablet daily
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Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints.
The maleic acid salt of Org 4420, code name Org 50081, was selected for development in the treatment of insomnia. The first clinical trial with Org 50081 was a proof-of-concept trial with a four-way cross-over design. All 3 Org 50081 dose groups showed a statistically significant positive effect on TST (objective and subjective) and WASO, as compared to placebo.
The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of Org 50081 50081 to investigate the safety and tolerability of long-term treatment with Org 50081 in elderly patients.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
fulfill the following criteria based on medical or sleep history. Each of these criteria should be present for at least 3 nights per week for at least one month;
Exclusion Criteria:
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 176005, P05697 |
Study First Received: | November 19, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00561574 |
Health Authority: | United States: Food and Drug Administration |
elderly randomized double blind |
Sleep Initiation and Maintenance Disorders Signs and Symptoms Mental Disorders Neurologic Manifestations |
Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Pathologic Processes Disease Nervous System Diseases |