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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00236015 |
The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD).
Condition | Intervention | Phase |
---|---|---|
Anxiety Disorder |
Drug: Gabitril |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Gabitril at 4, 8, and 12 Mg/Day in the Treatment of Adults With Generalized Anxiety Disorder. |
Estimated Enrollment: | 880 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | March 2006 |
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | C6671/3030/AX/US |
Study First Received: | October 7, 2005 |
Last Updated: | May 26, 2006 |
ClinicalTrials.gov Identifier: | NCT00236015 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Anxiety Disorders Tiagabine Mental Disorders |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action GABA Agonists |
Therapeutic Uses Physiological Effects of Drugs GABA Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |