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A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts

This study is not yet open for participant recruitment.
Verified June 2011 by Roxall Medizin
Sponsor:
Information provided by:
Roxall Medizin
ClinicalTrials.gov Identifier:
NCT01012752
First received: November 11, 2009
Last updated: June 9, 2011
Last verified: June 2011
History of Changes

November 11, 2009
June 9, 2011
November 2012
October 2013   (final data collection date for primary outcome measure)
Symptom and medication score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01012752 on ClinicalTrials.gov Archive Site
  • Safety of the treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Documentation of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Clinical global improvement [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts
A Multicenter, Double-Blind, Placebo-Controlled Study With a Modified Allergen Extract for Specific Immunotherapy in Patients With Seasonal Allergic Rhinitis/Rhinoconjunctivitis

This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Allergic Rhinitis
  • Allergic Conjunctivitis
  • Biological: modified allergen extract
    subcutaneous injections
  • Biological: Placebo
    subcutaneous injections
  • Active Comparator: modified allergen extract
    Intervention: Biological: modified allergen extract
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
January 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis
  • Positive screening skin prick test (wheal diameter > 3 mm)
  • Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
  • Signed and dated patient´s Informed Consent,

Exclusion Criteria:

  • Previous immunotherapy within the last 3 years,
  • Simultaneous participation in other clinical trials,
  • Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
  • Auto-immune disorders,
  • Severe chronic inflammatory diseases,
  • Malignancy,
  • Alcohol abuse,
  • Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
  • Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Both
18 Years to 65 Years
No
Contact: Roxall Medizin +49408972520
Germany
 
NCT01012752
SBC-2009-003B
Not Provided
Roxall Medizin
Roxall Medizin
Not Provided
Not Provided
Roxall Medizin
June 2011

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