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

NCT01625715 | Unknown Phase 2

• 1 other identifier: MCP-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

peanut allergy

Outcome Measures

Primary Outcomes (1)

• Adverse Event leading to discontinuation

  Treatment with peanut flour causes ADRs that lead to treatment discontinuation.

  up to 12 months

Secondary Outcomes (1)

• Clinical Global Assessment

  12 months

Study Arms (2)

Case control

NO INTERVENTION

Routine therapy during peanut desensitization

ketotifen

EXPERIMENTAL

rising doses of ketotifen

Drug: Ketotifen

Interventions

Ketotifen DRUG

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

ketotifen

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ≥ 8 years, all of either sex, any race, any ethnicity at the time of the initial visit
• The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal \>3.0 mm) and a positive in vitro IgE \[CAP-FEIA\] \> 7 kUA/L
• A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts
• Provide signed informed consent.

You may not qualify if:

• History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2 \< 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
• Currently participating in a study using an investigational new drug
• Participation in any interventional study for the treatment of food allergy in the past 12 months
• Subjects with a known oat or wheat (because of potential cross contamination with oat) food allergy will be excluded
• Poor control or persistent activation of atopic dermatitis
• Moderate to severe persistent asthma
• Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the NHLBI guidelines
• Inability to discontinue antihistamines for skin testing
• History of epilepsy or seizures
• Diabetes

Sponsors & Collaborators

• Gordon Sussman Clinical Research: lead
• Mast Cell Pharmaceuticals Inc.: collaborator

Study Sites (1)

GSCRI

Toronto, Ontario, M4V 1R2, Canada

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

Ketotifen

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gordon L Sussman, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

CA (1)