A Phase 3 interventional study of Depigoid Parietaria judaica 1000DPP/ml and Placebo in Allergic Rhinoconjunctivitis, sponsored by Laboratorios Leti, S.L.. Completed at 11 sites in Spain. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-11-11.
Sponsored by Laboratorios Leti, S.L. · Phase 3, Interventional, and Treatment
The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the score regarding symptoms and consumption of the medication.
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with two arms of treatment: placebo and active.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 153 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Laboratorios Leti, S.L. is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Positive Nasal provocation test Positive prick test to P. Judaica Specific IgE to P.Judaica >0,7KU/L
Exclusion Criteria:
A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml.
Biological: Depigoid Parietaria judaica 1000DPP/ml
Biological: Placebo
Subcutaneous monthly treatment
Also known as: A suspension of depigmented and glutaraldehyde-polymerised allergen extract of Parietaria judaica adsorbed onto aluminium hydroxide.
Subcutaneous monthly treatment
Symptoms score
Time frame: 2 years
Nasal Provocation test, Dose- response skin prick test, Quality of life questionnaire, visual scales, asthma symptom scores, Medication scores, adverse event and severity adverse event,unplanned healthcare resource utilization
Time frame: 2 years
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Laboratorios Leti, S.L.