CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Peanut flour OITdrug
Likely dose
Peanut flour OIT 4000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01324401
NCT01324401N/ACompleted
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Oral Peanut Immunotherapy

Massachusetts General Hospital·interventional·Posted Mar 29, 2011·Updated Aug 8, 2018

In Brief

A clinical study evaluating Peanut flour OIT for Peanut Allergy. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Peanut allergy is one of the most serious food allergies because of its life long persistence, and the potential for severe allergic reactions. Effective oral immunotherapy would benefit patients by reducing the likelihood that they will have life-threatening accidental allergic reactions. This research study is being done to develop an effective oral immunotherapy treatment for patients with peanut allergy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2011
Enrollment StartMar 1, 2011
Primary CompletionMay 1, 2016
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 15.3 years ago

Interventions

Peanut flour OITdrug

Patients will receive daily escalating dosages (Peanut flour OIT) as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.