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

This study has been terminated.

Sponsor:

Information provided by:

elbion AG

ClinicalTrials.gov Identifier:

NCT00322803

First received: May 5, 2006

Last updated: September 27, 2006

Last verified: September 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

May 5, 2006

Last Updated Date

September 27, 2006

Start Date ^ICMJE

May 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

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-Blind
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

Estimated 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)

Accepts Healthy Volunteers

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

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