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Biological Standardization of Dactylis Glomerata Allergen Extract

NCT01407835 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-08-09

No results posted yet for this study

Summary

The objective of this study is to determine the biologic activity of a Dactylis glomerata allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

Conditions

  • Allergy to Grass Pollen (Dactylis Glomerata)

Interventions

BIOLOGICAL

Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control

Four concentrations of Dactylis glomerata allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.

Sponsors & Collaborators

  • Laboratorios Leti, S.L.

    lead INDUSTRY

Principal Investigators

  • María José Gómez · Laboratorios LETI, S.L.Unipersonal

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-03-31
Completion
2012-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01407835 on ClinicalTrials.gov