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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

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

Page last updated: June 20, 2008

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