Peanut Allergies in ChildrenPhase 2NCT01625715
Pilot Study to Evaluate the Effect of Ketotifen on the Adverse Events Associated With Peanut Desensitization
A Phase 2 study testing Ketotifen in people with Peanut Allergies in Children, run by Gordon Sussman Clinical Research at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Peanut Allergies in Children
- What is being tested?
- Ketotifen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Peanut Allergies in Children
- Being tested
- Ketotifen
- Keywords
- peanut allergy
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetotifenDrug
titrated dose: 1 mg once a day, then 1 mg twice a day then 2 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Case control | No intervention | Routine therapy during peanut desensitization |
| ketotifen | Experimental | rising doses of ketotifen Receives: Drug: Ketotifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event leading to discontinuation
Treatment with peanut flour causes ADRs that lead to treatment discontinuation.
Measured: up to 12 months
Secondary outcomes (1)
Clinical Global Assessment
Investigator's assessment of treatment impact on moderating adverse reactions associated with desensitization.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut Allergies in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gordon Sussman Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Mast Cell Pharmaceuticals Inc.
- Responsible party
- Sponsor
- Investigators
- Gordon L Sussman, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625715
- Sponsor's protocol ID
- MCP-001
- Status last verified
- Jun 2012
- First submitted
- 19 Jun 2012
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01625715
- Acronym / sponsor ID
- MCP-001
- Conditions
- Peanut Allergies in Children
- Keywords
- peanut allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Gordon Sussman Clinical ResearchUniversity, hospital or other
- Collaborators
- Mast Cell Pharmaceuticals Inc.
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (estimated)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case control | No intervention | –Routine therapy during peanut desensitization |
| ketotifen | Experimental | Drug: Ketotifenrising doses of ketotifen |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketotifentitrated dose: 1 mg once a day, then 1 mg twice a day then 2 mg twice a day | Drug | ketotifen |
Primary outcome
Adverse Event leading to discontinuation
Time frame: up to 12 months
Treatment with peanut flour causes ADRs that lead to treatment discontinuation.
1 secondary outcome
Clinical Global Assessment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon L Sussman, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketotifen in people with Peanut Allergies in Children, run by Gordon Sussman Clinical Research at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event leading to discontinuation (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.