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Biological Standardization of Secale Cereale Allergen Extract

NCT01408238 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

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 Secale cereale allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

Conditions

  • Allergy to Grass Pollen (Secale Cereale)

Interventions

BIOLOGICAL

Four different concentrations of Secale cereale allergen extract, positive control and negative control

4 concentrations of Secale cereale 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 NCT01408238 on ClinicalTrials.gov