Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation (ALLEGRA6)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergopharma GmbH & Co. KG

ClinicalTrials.gov Identifier:

NCT00623701

First received: February 19, 2008

Last updated: March 8, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 19, 2008

Last Updated Date

March 8, 2013

Start Date ^ICMJE

March 2008

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Symptom and Medication Score [ Time Frame: Grass pollen season 2009 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00623701 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation

Official Title ^ICMJE

A Multicentre, Multinational, Placebo-controlled, Double-blind, Randomized Study to Evaluate Efficacy and Safety of a Perennial, Sublingual, Specific Immunotherapy in Patients With Rhinoconjunctivitis With/Without Controlled Asthma Caused by Grass Pollen

Brief Summary

Efficacy and Safety from a high-dosed sublingual grass pollen preparation

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, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Allergy
Rhinitis
Conjunctivitis

Intervention ^ICMJE

Biological: Allerslit forte
sublingual placebo preparation, daily
Biological: Allerslit forte
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily

Study Arm (s)

Placebo Comparator: 1
sublingual placebo preparation

Intervention: Biological: Allerslit forte
Experimental: 2
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose

Intervention: Biological: Allerslit forte

Publications *

Not Provided

* 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

126

Completion Date

October 2012

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Allergic rhinoconjunctivitis attributable to grass pollen
Positive SPT
Positive EAST
Positive provocation Test

Exclusion Criteria:

Serious chronic disease
other perennial allergies

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

Germany

Administrative Information

NCT Number ^ICMJE

NCT00623701

Other Study ID Numbers ^ICMJE

AL0703st, 2007-000823-16

Has Data Monitoring Committee

Responsible Party

Allergopharma GmbH & Co. KG

Study Sponsor ^ICMJE

Allergopharma GmbH & Co. KG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kristian Reich, Professor

not affiliated

Information Provided By

Allergopharma GmbH & Co. KG

Verification Date

March 2013

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

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