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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 study has been completed.
Study NCT00139854   Information provided by UCB, Inc.
First Received: August 29, 2005   Last Updated: September 9, 2009   History of Changes

August 29, 2005
September 9, 2009
August 2004
November 2004   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00139854 on ClinicalTrials.gov Archive Site
 
 
 
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
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.

See approved Package Insert for Adverse Event information.

Phase III
Interventional
Randomized, Open Label, Dose Comparison, Crossover Assignment
Anxiety
Drug: Alprazolam orally disintegrating tablets
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
November 2004
November 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently being treated with conventional alprazolam

Exclusion Criteria:

  • Dose of greater than 10 mg
Both
18 Years and older
 
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00139854
 
SP829
UCB, Inc.
 
Study Director: UCB Clinical Trial Call Center UCB, Inc.
UCB, Inc.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP