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Pilot Study to Evaluate the Effect of Ketotifen on the Adverse Events Associated With Peanut Desensitization

NCT01625715 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-06-21

No results posted yet for this study

Summary

The primary objective of this study is to evaluate, compared to non-treatment, the impact of a titrated dose (1 mg once a day, then 1 mg twice a day and finally a full 2 mg twice a day) of ketotifen on the adverse event profile emerging from a rapid peanut desensitization protocol, in children with established peanut allergy.

Conditions

  • Peanut Allergies in Children

Interventions

DRUG

Ketotifen

titrated dose: 1 mg once a day, then 1 mg twice a day then 2 mg twice a day

Sponsors & Collaborators

  • Mast Cell Pharmaceuticals Inc.

    collaborator INDUSTRY

  • Gordon Sussman Clinical Research

    lead OTHER

Principal Investigators

  • Gordon L Sussman, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-06-30
Completion
2012-09-30

Countries

  • Canada

Study Locations

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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 NCT01625715 on ClinicalTrials.gov