Status:
COMPLETED
Long-term Efficacy and Safety Study With Oralgen Grass Pollen
Lead Sponsor:
Artu Biologicals
Conditions:
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
18-51 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass poll...
Detailed Description
Allergy is one of the most common chronic diseases. Allergies to grass, weed, and tree pollens characteristically result in seasonal rhinitis symptoms commonly termed hay fever. The risk of developing...
Eligibility Criteria
Inclusion
- Patients who meet the in and exclusion criteria for study AB0602 and successfully finished this study.
- Patients who have given their written consent to participate in this study.
- Patients who are willing to comply with the protocol and understand the information given.
- Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method.
- Negative urine pregnancy test if female at the end of the previous study.
Exclusion
- Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
- Patients who were non-compliant during study AB0602.
- Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of this study.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT00824447
Start Date
August 1 2007
End Date
January 1 2009
Last Update
May 5 2010
Active Locations (39)
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1
MHAT PLovdiv, ENT Clinic
Plovdiv, Bulgaria
2
Military Medical Academy, Clinic of ENT
Sofia, Bulgaria, 1606
3
Military Medical Academy
Sofia, Bulgaria, 1606
4
5th MHAT, ENT Clinic
Sofia, Bulgaria