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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Gordon Sussman Clinical Research.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Mast Cell Pharmaceuticals Inc.
Information provided by (Responsible Party):
Gordon Sussman Clinical Research
ClinicalTrials.gov Identifier:
NCT01625715
First received: June 19, 2012
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Peanut Allergies in Children
Drug: Ketotifen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Case Controlled, Pilot Study to Evaluate the Effect of Ketotifen on the Adverse Events Associated With Peanut Desensitization in Children With Peanut Allergies.

Resource links provided by NLM:


Further study details as provided by Gordon Sussman Clinical Research:

Primary Outcome Measures:
  • Adverse Event leading to discontinuation [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Treatment with peanut flour causes ADRs that lead to treatment discontinuation.


Secondary Outcome Measures:
  • Clinical Global Assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Investigator's assessment of treatment impact on moderating adverse reactions associated with desensitization.


Estimated Enrollment: 6
Study Start Date: January 2011
Estimated Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Case control
Routine therapy during peanut desensitization
Experimental: ketotifen
rising doses of ketotifen
Drug: Ketotifen
titrated dose: 1 mg once a day, then 1 mg twice a day then 2 mg twice a day

Detailed Description:

The development of a safe oral peanut challenge procedure permits patients that do not have severe life threatening allergic reactions, to be safely desensitized with the ability to maintain peanut tolerance . The peanut desensitization procedure is however associated with unpleasant allergic side effects mainly gastrointestinal and cutaneous manifestations. The use of premedication drugs may lessen these side effects and facilitate the peanut desensitization procedure. Ketotifen is a fast acting, noncompetitive, H1-receptor blocker (antihistamine/inverse agonist) that also inhibits the release of mediators from mast cells involved in hypersensitivity reactions.

The study will enroll 6 (4 in the peanut treatment group, 2 in the control group) children with a known history of peanut allergies. The treated subjects will be randomized in a 2:1 ratio into either a pre-treatment group (final dose of 2 mg bid ketotifen) or a control group. All subjects will undergo a one-day peanut desensitization protocol designed to enable the subject to tolerate 50 mg of peanut flour (initial escalation phase). After the initial escalation day achieving up to 50 mg of peanut flour, the dosing build-up will occur every two weeks through 44 weeks. Subjects will ingest the 50mg and increased doses of peanut flour at home (every day for 2 weeks) between each dose escalation. The target dose is 8000 mg of peanut flour. A maintenance dose will be given for 4 weeks following the last (highest dose) visit.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. 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)
  2. Currently participating in a study using an investigational new drug
  3. Participation in any interventional study for the treatment of food allergy in the past 12 months
  4. Subjects with a known oat or wheat (because of potential cross contamination with oat) food allergy will be excluded
  5. Poor control or persistent activation of atopic dermatitis
  6. Moderate to severe persistent asthma
  7. Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the NHLBI guidelines
  8. Inability to discontinue antihistamines for skin testing
  9. History of epilepsy or seizures
  10. Diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625715

Locations
Canada, Ontario
GSCRI
Toronto, Ontario, Canada, M4V 1R2
Sponsors and Collaborators
Gordon Sussman Clinical Research
Mast Cell Pharmaceuticals Inc.
Investigators
Principal Investigator: Gordon L Sussman, MD
  More Information

No publications provided

Responsible Party: Gordon Sussman Clinical Research
ClinicalTrials.gov Identifier: NCT01625715     History of Changes
Other Study ID Numbers: MCP-001
Study First Received: June 19, 2012
Last Updated: June 20, 2012
Health Authority: Canada: Health Canada

Keywords provided by Gordon Sussman Clinical Research:
peanut allergy

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Ketotifen
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 18, 2014