NCT00310453

Brief Summary

The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_1

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

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

May 4, 2006

Status Verified

May 1, 2006

First QC Date

April 2, 2006

Last Update Submit

May 3, 2006

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • Assessment of safety by recording of adverse events

Interventions

ALK Grass tabletBIOLOGICAL

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Grass pollen induced rhinoconjunctivitis
  • Boys and girls, 5-12 years of age
  • Positive skin prick test to grass pollen

You may not qualify if:

  • Severe asthma
  • Previous treatment with immunotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Alergia, Hospital del Niño Jesús

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Kim Simonsen, MD

    ALK-Abelló A/S, Boege Alle 6-8, 2970 Hoersholm, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 2, 2006

First Posted

April 4, 2006

Study Start

March 1, 2006

Study Completion

May 1, 2006

Last Updated

May 4, 2006

Record last verified: 2006-05

Locations

ES(1)