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A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial

NCT00580606 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-08-21

Study results available
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Summary

The purpose of this study is to evaluate the safety and immune response to daily sublingual (under the tongue) immunotherapy (SLIT) with peanut extract in adults and children with peanut allergies.

Conditions

  • Food Hypersensitivity
  • Hypersensitivity
  • Immediate Hypersensitivity
  • Peanut Hypersensitivity

Interventions

DRUG

Glycerinated peanut allergenic extract

Glycerinated peanut extract delivered sublingually.

DRUG

Placebo for peanut extract (glycerin)

Placebo (glycerin) delivered sublingually.

Sponsors & Collaborators

  • Consortium of Food Allergy Research

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Wesley Burks, MD · Duke University

  • David Fleischer, MD · National Jewish Health

  • Hugh A. Sampson, MD · Icahn School of Medicine at Mount Sinai

  • Stacie Jones, MD · Arkansas Children's Hospital Research Institute

  • Robert Wood, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-12-31
Completion
2014-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00580606 on ClinicalTrials.gov