NCT02552537

Brief Summary

In patients with a walnut allergy double blind placebo controlled food challenge with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on threshold level and on clinical manifestation.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

September 14, 2015

Last Update Submit

May 10, 2017

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

  • amount of walnuts that induces an allergic reaction assessed in milligram

    The amount of walnut which induces an allergic reaction in walnut allergic patients will be assessed in milligram by titrated challenges under concommitant intake of therapeutic doses of omeprazole versus placebo

    up to 18 months

Study Arms (2)

Omeprazole

ACTIVE COMPARATOR

patients will take Omeprazole 40mg, in capsules, once a day, during five days before walnut challenge

Drug: Omeprazole

Placebo

SHAM COMPARATOR

patients will take Mannitol, in capsules, once a day, during five days before walnut challenge

Drug: Placebo

Interventions

OmeprazoleDRUG

patients with walnut allergy will be exposed during 5 days before food challenge with Omeprazole

Also known as: Omeprazol Sandoz eco Kps 40
Omeprazole
PlaceboDRUG

patients with walnut allergy will be exposed during 5 days before food challenge with Placebo

Also known as: Mannitol
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent, history of walnut allergy,minimum age 18 years

You may not qualify if:

  • Known hypersensitivity or allergy to Omeprazole, other proton pump inhibitors, mannitol, ingredients of placebo meal
  • Drugs not allowed during the study due to proved interaction with Omeprazole: Digoxin, Clopidogrel, Methotrexate, Antiretroviral drugs, Diazepam, Cilostazol, Phenytoin, Warfarin (R-Warfarin) and other Vitamin K antagonists, Phenytoin, Tacrolimus, Clarithromycin, voriconazole, Rifampicin and Hypericum
  • Drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge)
  • corticosteroids systemically (2 weeks)
  • antihistamines (3 days) except hydroxyzine (10 days)
  • ketotifen (2 weeks)
  • betablocker (1 day)
  • angiotensin converting enzyme (ACE) inhibitors (2 days)
  • omalizumab (2 months)
  • Women who are pregnant or breast feeding
  • Intention to become pregnant during the course of the study
  • Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices
  • Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
  • Uncontrolled asthma, forced expiratory volume \<70% predicted value
  • Acute allergic disease
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Clinico San Carlos

Madrid, Spain

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

OmeprazoleMannitol

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSugar AlcoholsAlcoholsCarbohydrates

Study Officials

  • Clare Mills, Prof, PhD

    University Manchester

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 17, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

ES(1)CH(1)