Clinical Trial: ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: International, Multicenter, Randomized, Double-Blind, Placebo Controlled, Two-Period, Cross-Over Study to Demonstrate Safety, Tolerability and Anxiolytic Effects of 600 mg ELB139 Given Orally t.i.d. t
Brief Summary: This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the first intake and after approximately one week of treatment as compared to placebo treatment.
Detailed Summary:
Sponsor: elbion AG
Current Primary Outcome:
- degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)
- difference of the degree of anxiety measured as the difference between the pre- and post challenge scores on the Visual Analogue Scale for Anxiety (VAS-A-delta)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Total Symptom Score assessed immediately after CO2 challenge (TSS-post)
- Difference of the Total Symptoms Score (TSS) measured as the difference between the pre- and post challenge scores (TSS-delta)
Original Secondary Outcome: Same as current
Information By: elbion AG
Dates:
Date Received: May 5, 2006
Date Started: May 2006
Date Completion: October 2006
Last Updated: September 27, 2006
Last Verified: September 2006
