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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00139854 |
This was a multicenter, open-label, randomized crossover trial comparing two treatments, Alprazolam ODT versus conventional alprazolam tablets, in subjects who were already taking conventional immediate-release alprazolam tablets for anxiety. The trial included five study visits (four periods of 7 3 -day duration): Screening (Visit 1), Treatment Period 1 (Visit 2), Treatment Period 2 (Visit 3), Final Visit (Visit 4), and Follow-up (Visit 5 [telephone visit]). At Visit 1, following screening, eligible subjects continued to take their own conventional alprazolam as prescribed by their physician. At Visit 2, eligible subjects were randomized in approximately equal numbers to one of two treatment sequences: Alprazolam ODT/ conventional alprazolam or conventional alprazolam/ Alprazolam ODT. Subjects continued taking alprazolam in accordance with the treatment sequence to which they were assigned, at the same dose regimen as their own prescribed alprazolam. At Visit 3, subjects crossed over to the alternate treatment until Visit 4. At Visit 4, subjects completed the Subject Preference Questionnaire, and a physical examination and clinical laboratory tests were performed. At the end of Visit 4, subjects resumed taking their own conventional alprazolam. The site made a follow-up telephone call 7 - 3 days after Visit 4 to assess the subject's health status.
Condition | Intervention | Phase |
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Anxiety |
Drug: Alprazolam orally disintegrating tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Dose Comparison, Crossover Assignment |
Official Title: | A Multicenter, Open-Label, Randomized Crossover Trial to Assess Subject Preference for Alprazolam Orally Disintegrating Tablets Compared to Conventional Alprazolam Tablets in Subjects With Anxiety |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SP829 |
Study First Received: | August 29, 2005 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00139854 History of Changes |
Health Authority: | United States: Institutional Review Board |
Neurotransmitter Agents Tranquilizing Agents Alprazolam Hypnotics and Sedatives |
Psychotropic Drugs Central Nervous System Depressants Anti-Anxiety Agents |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Pharmacologic Actions Alprazolam Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Central Nervous System Agents |