Status:
COMPLETED
MOA Study of Ze 339 in Seasonal Allergic Rhinitis
Lead Sponsor:
Max Zeller Soehne AG
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Randomised, double-blind and prospective clinical study to examine the mechanism of action of the Petasites hybridus leaf extract IG-RD-001 (Ze-339, petasol butenoate complex) compared to desloratadin...
Eligibility Criteria
Inclusion
- Allergic rhinitis since at least 2 years
- Age: = \> 18 years
- Consent in accordance with the AMG (=German Drug Law)
- Positive skin test, skin prick test or positive RAST for grasses The skin prick test is positive if the wheal is \>= 3 mm greater than control; a skin test is positive if the wheal is \>= 7 mm greater than control
- Women of childbearing potential have to use a highly effective method of birth control (according CPMP/ICH/286/95 Note 3) during the duration of the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Exclusion
- Past or current psychological disease or disorder which can impair the study participant's ability to understand the study requirements, t take part in the study or give consent after briefing
- Past or current alcohol or medication dependency or abuse
- Bronchial asthma (FEV \< 80 %)
- Glaucoma, cataract or ocular herpes simplex
- Clinically relevant deviations from normal laboratory parameters (if known)
- Antihistamines with a long-term effect
- Malignant diseases, including in the patient's case history
- Parasites
- Study participants who are taking part in another study or took an investigational product during the last 4 weeks before the start of treatment
- Progressive systemic diseases such as tuberculosis, leukoses, collagenoses, multiple sclerosis, Aids, HIV infection and other autoimmune diseases
- Other types of rhinitis with different causes, acute or chronic sinusitis
- Pregnancy or lactation
- Serious internal diseases, e.g. serious decompensated diseases of the heart, liver, kidneys or diabetes mellitus
- Patients with rarely occurring hereditary problems galactose-intolerance, Lapp-lactase-deficiency or glucose-galactose-malabsorption
- Pre-existing liver damage
- The use of non-steroidal antirheumatic agents (NSAR)
- Hypersensitivity towards one of the ingredients in the investigational product
- Not adhering to the following periods of abstention before the nasal provocation test: 3 days for DNCG, nedocromil, nasal and oral antihistamines, and tricyclic psychotropic drugs, 1 months systemic treatment with glucocorticoids, 14 days for nasal and topical corticosteroids, 1 week for antihistamines, and 1 day for α-adrenergic drugs. The use of ACE inhibitors or ß-blockers
- Previous organ transplants
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00862225
Start Date
January 1 2008
End Date
December 1 2008
Last Update
January 26 2012
Active Locations (1)
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1
Dept. of Otorhinolaryngology and Head and Neck Surgery
Düsseldorf, Germany