ELB139 Given Orally to Patients With Concurrent Panic Dis... | NCT00322803

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

NCT00322803

Sponsor

elbion AG

Status

Terminated

Last Update Posted

Sep 29, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Panic Disorder

Interventions

ELB139

Countries

Germany
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT Number:2005-005708-17

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. to Patients With Concurrent Panic Disorder, Challenged by Inhalation of 35% CO2 After a Single Dose and One Week of Treatment

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Oct 2006

First Submitted Date

May 5, 2006

First Submission Date that Met QC Criteria

May 5, 2006

First Posted Date

May 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2006

Last Update Posted Date

Sep 29, 2006Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
ELB139	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Griez, Prof Dr	Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité - University Clinics Berlin		Berlin		10117	Germany
Emovis, The institute of emotional health

Condition Browse Module

MeSH Terms

ID	Term
D016584	Panic Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C504151	1-(4-chlorophenyl)-4-piperidin-1-yl-1,5-dihydroimidazol-2-one

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided