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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

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ClinicalTrials.gov Identifier: NCT00139854
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : August 30, 2013
Sponsor:
Information provided by:
UCB Pharma

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 subject's health status.

Condition or disease Intervention/treatment Phase
ANXIETY Drug: Alprazolam orally disintegrating tablets Phase 3

Detailed Description:
See approved Package Insert for Adverse Event information.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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 Start Date : August 2004
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Alprazolam





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Currently being treated with conventional alprazolam

Exclusion Criteria:

  • Dose of greater than 10 mg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139854


Locations
United States, Wisconsin
Schwarz
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma

Additional Information:
ClinicalTrials.gov Identifier: NCT00139854     History of Changes
Other Study ID Numbers: SP829
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: September 2009

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