Peanut Allergy Oral Immunotherapy Desensitization

NCT01601522 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2022-02-02

No results posted yet for this study

Summary

The purpose of the study is to determine how a type of treatment for peanut allergy known as oral desensitization works in the immune system.

Objectives

1. To determine whether premedication with desloratidine and ranitidine results in fewer side effects during desensitization procedure.
2. To assess quality of life in peanut allergic subjects before and after desensitization.
3. To compare serum metabolites in peanut allergic and non peanut allergic subjects.

Conditions

Interventions

PROCEDURE

Peanut protein

500 mg

PROCEDURE

Oat flour

500 mg Oat flour

DRUG

Antihistamine

Desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) Ranitidine 5ml (15mg/ml=75 mg) po bid

Sponsors & Collaborators

  • AllerGen NCE Inc.

    collaborator INDUSTRY
  • McMaster University

    collaborator OTHER
  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Susan Waserman, ME · McMaster University

  • Susan Waserman, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Canada

Study Locations

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Entities

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 NCT01601522 on ClinicalTrials.gov