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
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),...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
- Study Primary Completion Date: November 2004
Detailed Clinical Trial Description
See approved Package Insert for Adverse Event information.
Intervention(s) in this Clinical Trial
- Drug: Alprazolam orally disintegrating tablets
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Currently being treated with conventional alprazolam
Exclusion Criteria:
- Dose of greater than 10 mg
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Investigator Information
Lead Investigator: UCB, Inc. Industry
Overall Clinical Trial Officials and Contacts
UCB Clinical Trial Call Center Study Director UCB, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 02, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139854
Study ID Number: SP829
ClinicalTrials.gov Identifier: NCT00139854
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00139854
