ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment

Tracking Information
First Submitted Date ICMJE	May 5, 2006
First Posted Date ICMJE	May 8, 2006
Last Update Posted Date	September 29, 2006
Study Start Date ICMJE	May 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: May 5, 2006)	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 Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00322803 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 5, 2006)	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 Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment
Official Title ICMJE	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. to Patients With Concurrent Panic Disorder, Challenged by Inhalation of 35% CO2 After a Single Dose and One Week of Treatment
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 Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Panic Disorder
Intervention ICMJE	Drug: ELB139
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Enrollment ICMJE; (submitted: May 5, 2006)	24
Original Enrollment ICMJE	Same as current
Study Completion Date	October 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Diagnosis of concurrent panic disorder; At least 2 panic attacks within the 4 weeks before the screening visit; Naïve to the CO2 challenge test; Age 18–65 years (inclusive); Ability to comply with all procedures mandated by the study protocol; Negative pregnancy test and adequate contraceptive measures Exclusion Criteria: History of poly-pharmacotherapy for panic disorder or treatment resistance; Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia; History of abuse of benzodiazepines or tolerance to effects of benzodiazepine; Any concomitant psychotropic medication; Evidence of impaired hepatic, renal or cardiac functions; Participation in any drug trial in the preceding 6 months
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Germany, Netherlands
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00322803
Other Study ID Numbers ICMJE	ELB139202-05; EudraCT Number:2005-005708-17
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	elbion AG
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Eric Griez, Prof Dr Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
PRS Account	elbion AG
Verification Date	September 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP