Assessment of Grazax® Treatment Compliance | NCT00293046

Studies
Assessment of Grazax® Treatment Compliance

NCT00293046

Sponsor

ALK-Abelló A/S

Status

Completed

Last Update Posted

Sep 30, 2008Estimated

Enrollment

500

Phase

Phase 3

Conditions

Allergy

Interventions

ALK Grass tablet - use of compliance device

Countries

Austria

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

Sep 2008

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

Feb 2006

Primary Completion Date

Sep 2006Actual

Completion Date

Oct 2007Actual

First Submitted Date

Feb 16, 2006

First Submission Date that Met QC Criteria

Feb 16, 2006

First Posted Date

Feb 17, 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 29, 2008

Last Update Posted Date

Sep 30, 2008Estimated

Description Module

Brief Summary

This trial is performed to assess whether the Grazax® treatment compliance can be improved by use of a compliance device (Memozax®).

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

500

Name	Type	Description	Arm Group Labels	Other Names
ALK Grass tablet - use of compliance device	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of treatment compliance by recording of drug accountability

Secondary Outcomes

Measure	Description	Time Frame
Recording of adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Grass pollen induced rhinoconjunctivitis
Males and females, 18-65 years of age
Positive skin prick test

Exclusion Criteria:

Previous treatment with grass pollen allergen

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
Kim Simonsen, MD	ALK-Abelló A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allgergie - Ambulatorium Rennweg		Vienna		1030	Austria