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A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy

NCT01084174 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-04-07

Study results available
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Summary

The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.

Conditions

  • Peanut Hypersensitivity
  • Food Hypersensitivity
  • Immediate Hypersensitivity

Interventions

DRUG

Peanut powder

Delivered orally

DRUG

Peanut extract

Delivered sublingually

DRUG

Placebo extract

Delivered sublingually

DRUG

Placebo powder

Delivered orally

Sponsors & Collaborators

Principal Investigators

  • Robert Wood, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01084174 on ClinicalTrials.gov