NCT00309036

Brief Summary

The trial is performed to assess efficacy and safety of a recombinant grass Pollen allergen cocktail in allergic rhinoconjunctivitis

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2004

Typical duration for phase_3

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

January 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

2.7 years

First QC Date

March 30, 2006

Last Update Submit

March 8, 2013

Conditions

Allergy

Keywords

AllergyGrass pollenRecombinant

Interventions

Recombinant grass pollenBIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive Skin Prick Test reaction to grass pollen
  • Positive RAST result to grass pollen
  • Positive Provocation Test result to grass pollen

You may not qualify if:

  • Serious chronic diseases
  • Other relevant perennial allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergopharma GmbH & Co. KG

Reinbek, 21465, Germany

Location

Related Links

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Annemie Narkus, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2006

First Posted

March 31, 2006

Study Start

January 1, 2004

Primary Completion

September 1, 2006

Study Completion

May 1, 2008

Last Updated

March 11, 2013

Record last verified: 2013-03

Locations

DE(1)