Long-Term Study of IGE025 in Moderate to Severe Bronchial... | NCT00219323

Studies
Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.

NCT00219323

Sponsor

Novartis

Status

Completed

Last Update Posted

Oct 25, 2011Estimated

Enrollment

133Actual

Phase

Phase 3

Conditions

Asthma

Interventions

Omalizumab

Countries

Japan

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

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Sep 21, 2005

First Submission Date that Met QC Criteria

Sep 21, 2005

First Posted Date

Sep 22, 2005Estimated

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

Oct 24, 2011

Last Update Posted Date

Oct 25, 2011Estimated

Name	Class
Daiichi Sankyo Co., Ltd.	INDUSTRY

Description Module

Brief Summary

This study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult patients with moderate to severe bronchial asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

133Actual

Name	Type	Description	Arm Group Labels	Other Names
Omalizumab	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of omalizumab

Secondary Outcomes

Measure	Description	Time Frame
Pulmonary function parameters measured by spirometer
Morning and evening peak expiratory flow (PEF)
Symptoms score, treatment score, activities of daily living score, nighttime sleep score, and asthma score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Allergic asthma patients
Inadequately controlled patients

Exclusion Criteria:

- History of severe anaphylactoid or anaphylactic reactions
Previous treatment with omalizumab
History of cancer or cancer

Other protocol-defined exclusion criteria may apply.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 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
Novartis Pharmaceuticals Japan	Novartis Pharmaceuticals Japan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
This study is not being conducted in the United States		Tokyo			Japan

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
C562694	Epilepsy, Idiopathic Generalized

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069444	Omalizumab

Ancestor Terms

ID	Term
D000888	Antibodies, Anti-Idiotypic
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins

Browse Leaves

Not provided

Browse Branches

Not provided