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NCT00139854 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
NCT00139854 is a Phase 3 study that has completed, run by UCB Pharma.
The verdict
NCT00139854, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
Study 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.
Interventions
- DRUG Alprazolam orally disintegrating tablets
Trial Details
| Field | Value |
|---|---|
| Start Date | 2004-08 |
| Est. Completion | 2004-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00139854
The ClinicalTrials.gov registry entry for NCT00139854 describes a study currently listed as completed, categorized as Phase 3. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is UCB Pharma, which has 100 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alprazolam orally disintegrating tablets is the first listed.
NCT00139854 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00139854 about?
NCT00139854 is a clinical study titled "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...
What is the current status of trial NCT00139854?
This trial is currently completed. It is a Phase 3 study. The study started on 2004-08. Estimated completion is 2004-11.
What interventions are being tested in trial NCT00139854?
The interventions under investigation include: Alprazolam orally disintegrating tablets (DRUG).
Who is sponsoring clinical trial NCT00139854?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
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