Phase
Condition
Heartburn (Pediatric)
Esophageal Disorders
Heartburn
Treatment
EP-104IAR
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.
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;
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
Princess Alexandra Hospital
Brisbane, Queensland
AustraliaActive - Recruiting
Royal Adelaide Hospital
Adelaide, South Australia
AustraliaActive - Recruiting
G.I. Research Institute
Vancouver, British Columbia V6Z 2K5
CanadaActive - Recruiting
McGill University Health Center
Montréal, Quebec
CanadaActive - Recruiting
Amsterdam UMC
Amsterdam, 1105
NetherlandsActive - Recruiting
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