A Trial of the ALK Grass Tablet in Subjects With Hayfever

January 28, 2013 updated by: ALK-Abelló A/S

A Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of ALK Grass Tablet in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

634

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Eligibility Criteria:

  • A history of grass pollen induced rhinoconjunctivitis
  • Positive skin prick test to grass
  • Positive specific IgE to grass

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: ALK Grass tablet
Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years
Placebo Comparator: 2
Biological: ALK Grass tablet
Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recording of rhinoconjunctivitis symptoms
Time Frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009
Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009
Recording of use of rescue medication
Time Frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009
Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009
Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Investigators

  • Study Director: Bente Tholstrup, MSc, ALK-Abelló A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 26, 2005

First Submitted That Met QC Criteria

September 26, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GT-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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