A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00773240
First received: October 15, 2008
Last updated: August 27, 2011
Last verified: August 2011

October 15, 2008
August 27, 2011
April 2008
October 2008   (final data collection date for primary outcome measure)
Pharmacodynamics - Immunological assessments [ Time Frame: Pre- and post treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00773240 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment
A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment Initiated in the Grass Pollen Season in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

The study assess the pharmacodynamic effect and the tolerability of Grazax treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Grass Pollen Allergy
  • Drug: Grazax
    1 tablet, 75,000 SQ-T, daily during the trial period
  • Drug: placebo
    1 placebo tablet, matching the active treatment, daily during the trial period
  • Experimental: 1
    Grazax
    Intervention: Drug: Grazax
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Reich K, Gessner C, Kroker A, Schwab JA, Pohl W, Villesen H, Wüstenberg E, Emminger W. Immunologic effects and tolerability profile of in-season initiation of a standardized-quality grass allergy immunotherapy tablet: a phase III, multicenter, randomized, double-blind, placebo-controlled trial in adults with grass pollen-induced rhinoconjunctivitis. Clin Ther. 2011 Jul;33(7):828-40. Epub 2011 Jul 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
276
February 2009
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Positive skin prick test to Phleum pratense
  • Positive IgE to Phleum pratense
  • signed informed consent
  • A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms

Exclusion Criteria:

  • No uncontrolled asthma in the past 12 months
  • No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
  • No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00773240
GT-18
No
ALK-Abelló A/S
ALK-Abelló A/S
Not Provided
Study Director: Kim Simonsen, MD ALK-Abelló A/S
ALK-Abelló A/S
August 2011

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