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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.
Sponsored by: UCB
Information provided by: UCB
ClinicalTrials.gov Identifier: NCT00139854
  Purpose

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.


Condition Intervention Phase
Anxiety
Drug: Alprazolam orally disintegrating tablets
Phase III

MedlinePlus related topics: Anxiety
Drug Information available for: Alprazolam
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Dose Comparison, Crossover Assignment
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

Further study details as provided by UCB:

Study Start Date: August 2004
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Detailed Description:

See approved Package Insert for Adverse Event information.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Currently being treated with conventional alprazolam

Exclusion Criteria:

  • Dose of greater than 10 mg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139854

Locations
United States, Wisconsin
Schwarz
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
UCB
Investigators
Study Director: Patricia Witt UCB
  More Information

Study ID Numbers: SP829
Study First Received: August 29, 2005
Last Updated: April 16, 2008
ClinicalTrials.gov Identifier: NCT00139854  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Alprazolam

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Pharmacologic Actions
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009