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Sponsored by: |
Laboratorios Leti, S.L. |
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Information provided by: | Laboratorios Leti, S.L. |
ClinicalTrials.gov Identifier: | NCT00718744 |
The main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended
Condition | Intervention | Phase |
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Rhinitis, Allergic, Seasonal Conjunctivitis, Allergic |
Other: Standardization of allergenic extract (Ch. arcuatus) |
Phase II |
Study Type: | Interventional |
Study Design: | Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Standardization of Chortoglyphus Arcuatus Allergenic Extract. Determination of Biological Activity in HEP Units |
Enrollment: | 30 |
Study Start Date: | June 2008 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
In each individual patient, 10 mg/ml histamine dihydrochloride solution and a phenolated saline solution will be applied as positive and negative control respectively.
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Other: Standardization of allergenic extract (Ch. arcuatus)
Allergenic extract for cutaneous prick-test
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The skin testing procedure, based on the Nordic Guidelines is the reference method for the biological calibration of in-House Reference Preparations (IHRP). The method is not intended for routine testing of allergen extracts. The use of this procedure is the basis for the definition of biological activity units: "the activity of an allergen extract is 10,000 Biological Units (BU) per ml (10 HEP per ml), when the extract provokes an specific skin reaction in the median sensitive patient with a wheal of the same size as a wheal provoked by a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned".
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Laboratorios LETI S.L.Unipersonal ( María José Gómez ) |
Study ID Numbers: | 2005-001194-96 |
Study First Received: | July 17, 2008 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00718744 |
Health Authority: | Spain: Spanish Agency of Medicines |
Allergen-extract Standardization |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Conjunctivitis, Allergic Eye Diseases |
Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Rhinitis Conjunctivitis Conjunctival Diseases Respiratory Hypersensitivity |
Immune System Diseases Nose Diseases |