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

ANXIETY Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139854
• Other study ID #: SP829
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: August 29, 2013
• Start date: August 2004
• Est. completion date: November 2004

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

See approved Package Insert for Adverse Event information.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Currently being treated with conventional alprazolam

Exclusion Criteria:

• Dose of greater than 10 mg

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• ANXIETY
• Anxiety Disorders

Intervention

Drug:
• Alprazolam orally disintegrating tablets

Locations

Country	Name	City	State
United States	Schwarz	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

External Links

•   Clinical Study Summary on UCB.com