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
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety
Intervention: Alprazolam orally disintegrating tablets (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Patricia Witt, Study Director, Affiliation: UCB
Summary
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.
Clinical Details
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: Randomized, Open Label, Dose Comparison, Crossover Assignment
Detailed description:
See approved Package Insert for Adverse Event information.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Currently being treated with conventional alprazolam
Exclusion Criteria:
- Dose of greater than 10 mg
Locations and Contacts
Schwarz, Milwaukee, Wisconsin, United States
Additional Information
Starting date: August 2004
Ending date: November 2004
Last updated: April 16, 2008
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