Study of Tolerance to Oral Peanut (STOP)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2010 by Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Cambridge University Hospitals NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT01259804

First received: December 13, 2010

Last updated: September 9, 2011

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 13, 2010

Last Updated Date

September 9, 2011

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pass/fail peanut challenge [ Time Frame: six months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01259804 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Tolerance to Oral Peanut

Official Title ^ICMJE

Efficacy and Safety of High-dose Peanut Oral Immunotherapy With Factors Predicting Outcome

Brief Summary

Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy

Detailed Description

Background Peanut allergy is severe and rarely resolves.

Objective To test the efficacy and safety of a new oral immunotherapy protocol for peanut allergy.

Method 22 peanut-allergic children will undergo oral challenge. Oral immunotherapy will be administered by gradual updosing with 2-weekly increments (8-38w) to 800mg protein (5 peanuts/day) followed by 30-weeks maintenance. Oral challenge will be repeated after 6 and 30 weeks maintenance.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Peanut Allergy

Intervention ^ICMJE

Dietary Supplement: Peanut oral immunotherapy

Daily doses of peanut flour

Other Name: Daily doses peanut flour

Study Arm (s)

Experimental: Peanut immunotherapy

Peanut flour

Intervention: Dietary Supplement: Peanut oral immunotherapy

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

January 2012

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Peanut allergy defined by oral challenge

Exclusion Criteria:

Major immunodeficiency

Gender

Both

Ages

7 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01259804

Other Study ID Numbers ^ICMJE

STOP-I

Has Data Monitoring Committee

Responsible Party

Mr Stephen Kelliher, Head of R and D, Cambridge University Hospitals NHS Trust

Study Sponsor ^ICMJE

Cambridge University Hospitals NHS Foundation Trust

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Andrew T Clark, MB BD MD

Cambridge Biomedical Campus

Information Provided By

Cambridge University Hospitals NHS Foundation Trust

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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