NCT00293046

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 30, 2008

Status Verified

September 1, 2008

Enrollment Period

7 months

First QC Date

February 16, 2006

Last Update Submit

September 29, 2008

Conditions

Allergy

Keywords

Allergy

Outcome Measures

Primary Outcomes (1)

  • Assessment of treatment compliance by recording of drug accountability

Secondary Outcomes (1)

  • Recording of adverse events

Interventions

ALK Grass tablet - use of compliance deviceBIOLOGICAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous treatment with grass pollen allergen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allgergie - Ambulatorium Rennweg

Vienna, 1030, Austria

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Kim Simonsen, MD

    ALK-Abelló A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 17, 2006

Study Start

February 1, 2006

Primary Completion

September 1, 2006

Study Completion

October 1, 2007

Last Updated

September 30, 2008

Record last verified: 2008-09

Locations

AU(1)