Phase
Condition
Esophageal Disorders
Heartburn (Pediatric)
Heartburn
Treatment
EP-104IAR
EP-104GI
Matching vehicle control
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Symptomatic EoE;
For women of childbearing potential, a negative pregnancy test and willing to use ahighly effective method of birth control until end of study;
Willing and able to adhere to study-related procedures and visit schedule;
Willing and able to provide informed consent.
Criteria for crossover to EP 104GI from vehicle control (randomized dose optimization portion):
Has completed the randomized dose optimization portion of the trial to Week 24,inclusive
Without safety concerns for receiving EP 104GI ie, does not meet exclusion criteriaor have other safety issue
Exclusion
Exclusion Criteria:
Concomitant esophageal disease, relevant GI disease, or any condition, history, orlaboratory abnormality that might interfere with the study;
Oral or esophageal mucosal infection of any type (bacterial, viral, or fungal);
Oropharyngeal or dental conditions that prevents normal eating;
Severe esophageal motility disorders other than EoE;
Contraindication to or factors that substantially increase risks associated with EGDor biopsy, or narrowing of the esophagus that precludes EGD with a standard 9-10 mmendoscope, stricture requiring dilation within 8 weeks prior to Screening, or theneed for dilation prior to EGD at Baseline;
Any condition for which the use of corticosteroids is contraindicated (Participantswith well controlled non-insulin dependent diabetes are permitted);
Active or quiescent systemic fungal, bacterial, viral, or parasitic infections, orocular herpes simplex. Or recent use of IV or oral antibiotics;
Hypersensitivity, or intolerance to corticosteroids, or to any of the ingredients inthe investigational medicinal product, including carboxymethyl cellulose, andpolysorbate 80, or to the ingredients in Synacthen / cosyntropin (used in the ACTHstimulation test);
Recent use of disallowed medications, or unwillingness to not use disallowedmedications during the study;
Recent initiation of a elimination or elemental diet (dietary therapy must remainstable throughout the study);
Morning serum cortisol level ≤ 5 μg/dL (138 nmol/L);
Clinically significant abnormal laboratory values;
Recent or currently planned participation in another interventional trial ;
Previous participation in this study and had received study treatment;
Females who are pregnant, breastfeeding, or planning to become pregnant during thestudy;
Malignancies or history of malignancy within prior 5 years, except for treated orexcised non-metastatic BCC, SCC of the skin, or cervical carcinoma in situ;
History of alcohol or drug abuse;
Any other reason, that, in the Investigator's opinion, unfavorably altersparticipant risk, confounds results, or prevents the participant from complying withstudy requirements.
Study Design
Connect with a study center
Campbelltown Private Hospital
Sydney, New South Wales
AustraliaActive - Recruiting
Campbelltown Private Hospital
Sydney 2147714, New South Wales 2155400
AustraliaSite Not Available
Mater Hospital Brisbane
Brisbane, Queensland
AustraliaActive - Recruiting
Princess Alexandra Hospital
Brisbane, Queensland
AustraliaActive - Recruiting
Coastal Digestive Health
Maroochydore, Queensland
AustraliaActive - Recruiting
Mater Hospital Brisbane
Brisbane 2174003, Queensland 2152274
AustraliaActive - Recruiting
Princess Alexandra Hospital
Brisbane 2174003, Queensland 2152274
AustraliaSite Not Available
Coastal Digestive Health
Maroochydore 2207268, Queensland 2152274
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia
AustraliaActive - Recruiting
Royal Adelaide Hospital
Adelaide 2078025, South Australia 2061327
AustraliaSite Not Available
Eastern Health Box Hill
Box Hill, Victoria 3128
AustraliaActive - Recruiting
Northern Hospital Epping
Epping, Victoria
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria
AustraliaActive - Recruiting
Royal Melbourne Hospital
Parkville, Victoria
AustraliaActive - Recruiting
Eastern Health Box Hill
Box Hill 2174360, Victoria 2145234 3128
AustraliaSite Not Available
Northern Hospital Epping
Epping 2167279, Victoria 2145234
AustraliaSite Not Available
The Alfred Hospital
Melbourne 2158177, Victoria 2145234
AustraliaSite Not Available
Royal Melbourne Hospital
Parkville 2153770, Victoria 2145234
AustraliaSite Not Available
University of Calgary
Calgary, Alberta
CanadaActive - Recruiting
UoA - South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta
CanadaActive - Recruiting
University of Calgary
Calgary 5913490, Alberta 5883102
CanadaSite Not Available
UoA - South Edmonton Gastroenterology Research Clinic
Edmonton 5946768, Alberta 5883102
CanadaSite Not Available
G.I. Research Institute
Vancouver, British Columbia V6Z 2K5
CanadaActive - Recruiting
G.I. Research Institute
Vancouver 6173331, British Columbia 5909050 V6Z 2K5
CanadaSite Not Available
McGill University Health Center
Montreal, Quebec
CanadaActive - Recruiting
McGill University Health Center
Montréal, Quebec
CanadaSite Not Available
McGill University Health Center
Montreal 6077243, Quebec 6115047
CanadaSite Not Available
Amsterdam UMC
Amsterdam, 1105
NetherlandsSite Not Available
Amsterdam UMC
Amsterdam 2759794, 1105
NetherlandsSite Not Available
Erasmus University Medical Center
Holland,
NetherlandsActive - Recruiting
Aotearoa Clinical Trials
Papatoetoe, Auckland
New ZealandActive - Recruiting
Aotearoa Clinical Trials
Papatoetoe 6232008, Auckland 2193734
New ZealandSite Not Available
Waikato Hospital
Hamilton,
New ZealandActive - Recruiting
Capital Coast and Hutt
Lower Hutt,
New ZealandActive - Recruiting
Capital Coast and Hutt
Lower Hutt 2188164,
New ZealandSite Not Available
Universitätsspital Zürich
Zurich,
SwitzerlandActive - Recruiting
Universitätsspital Zürich
Zurich 2657896,
SwitzerlandSite Not Available
Norfolk and Norwich University Hospital
Norwich, Norfolk
United KingdomActive - Recruiting
Norfolk and Norwich University Hospital
Norwich 2641181, Norfolk
United KingdomSite Not Available
Cardiff and Vale University Health Board-Wales
Cardiff,
United KingdomActive - Recruiting
Cardiff and Vale University Health Board-Wales
Cardiff 2653822,
United KingdomSite Not Available
Royal Liverpool University Hospital
Liverpool,
United KingdomActive - Recruiting
St George's University of London
London,
United KingdomActive - Recruiting

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