Clinical Trial: 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: Schwarz Pharma
Information provided by: Schwarz Pharma
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 consumer health information 

Study Type: Interventional
Study Design: Randomized, Open Label, Dose Comparison, Crossover Assignment

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • currently being treated with conventional alprazolam

Exclusion Criteria:

  • Dose of greater than 10 mg

Location Information


Wisconsin
      Schwarz, Mequoin,  Wisconsin,  United States

Study chairs or principal investigators

Patricia Witt,  Study Director,  Schwarz Pharma   

More Information

Study ID Numbers:  SP829
Last Updated:  August 30, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00139854
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13

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