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
Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ANXIETY
Intervention: Alprazolam orally disintegrating tablets (Drug)
Phase: Phase 3
Sponsored by: UCB Pharma
Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: UCB Pharma
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.
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
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
See approved Package Insert for Adverse Event information.
Minimum age: 18 Years.
Maximum age: N/A.
- Currently being treated with conventional alprazolam
- Dose of greater than 10 mg
Locations and Contacts
Schwarz, Milwaukee, Wisconsin, United States
Clinical Study Summary on UCB.com
Starting date: August 2004
Last updated: August 29, 2013