NCT00263549

Brief Summary

The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic Rhinoconjunctivitis

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_4

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

September 1, 2002

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

2.4 years

First QC Date

December 8, 2005

Last Update Submit

February 8, 2013

Conditions

House Dust Mite Allergy

Keywords

House dust mite,Allergy

Interventions

House dust mite Novo Helisen DepotBIOLOGICAL

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive skin prick test to house dust mite,
  • Positive RAST test to house dust mite,
  • Positive provocation test result to house dust mite,

You may not qualify if:

  • Serious chronic diseases,
  • Other 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

Dust Mite AllergyHypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, PerennialRhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System Diseases

Study Officials

  • Annemie Narkus, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2005

First Posted

December 9, 2005

Study Start

September 1, 2002

Primary Completion

February 1, 2005

Study Completion

February 1, 2006

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

DE(1)