Pilot Study to Evaluate the Effect of Ketotifen on the Adverse Events Associated With Peanut Desensitization
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|ClinicalTrials.gov Identifier: NCT01625715|
Recruitment Status : Unknown
Verified June 2012 by Gordon Sussman Clinical Research.
Recruitment status was: Active, not recruiting
First Posted : June 21, 2012
Last Update Posted : June 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergies in Children||Drug: Ketotifen||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||September 2012|
No Intervention: Case control
Routine therapy during peanut desensitization
rising doses of ketotifen
titrated dose: 1 mg once a day, then 1 mg twice a day then 2 mg twice a day
- Adverse Event leading to discontinuation [ Time Frame: up to 12 months ]Treatment with peanut flour causes ADRs that lead to treatment discontinuation.
- Clinical Global Assessment [ Time Frame: 12 months ]Investigator's assessment of treatment impact on moderating adverse reactions associated with desensitization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625715
|Toronto, Ontario, Canada, M4V 1R2|
|Principal Investigator:||Gordon L Sussman, MD|