Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139854
Status:
COMPLETED
Last Update Posted:
2013-08-30
First Post:
2005-08-29
Brief 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
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 subjects health status
Detailed Description:
See approved Package Insert for Adverse Event information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None