A Trial of the ALK Grass Tablet in Subjects With Hayfever

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ALK-Abelló A/S

ClinicalTrials.gov Identifier:

NCT00227279

First received: September 26, 2005

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 26, 2005

Last Updated Date

January 28, 2013

Start Date ^ICMJE

October 2004

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Recording of rhinoconjunctivitis symptoms [ Time Frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 ] [ Designated as safety issue: No ]
Recording of use of rescue medication [ Time Frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Recording of rhinoconjunctivitis symptoms
Recording of use of rescue medication

Change History

Complete list of historical versions of study NCT00227279 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of life [ Time Frame: Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Quality of life

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Trial of the ALK Grass Tablet in Subjects With Hayfever

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Allergy

Intervention ^ICMJE

Biological: ALK Grass tablet

Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years

Study Arm (s)

Experimental: 1
Intervention: Biological: ALK Grass tablet
Placebo Comparator: 2
Intervention: Biological: ALK Grass tablet

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

634

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Eligibility Criteria:

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00227279

Other Study ID Numbers ^ICMJE

GT-08

Has Data Monitoring Committee

Not Provided

Responsible Party

ALK-Abelló A/S

Study Sponsor ^ICMJE

ALK-Abelló A/S

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bente Tholstrup, MSc

ALK-Abello A/S

Information Provided By

ALK-Abelló A/S

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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