Clinical trial NCT02280616 (phase 2, status: completed)
Conditions: eosinophilic esophagitis
ICD codes: K20.0
Drugs: low dose budesonide tablet, high dose budesonide tablet, high dose budesonide suspension, placebo
SMILES: [H][C@@]12C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [H][C@@]12C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [H][C@@]12C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Major Inclusion Criteria:

          -  Signed informed consent

          -  Male or female patients, 18 to 75 years of age

          -  Confirmed clinicopathological diagnosis of EoE according to established diagnostic
             criteria:

        (A) Clinical symptoms of esophageal dysfunction (B) Peak eosinophils ≥ 15 in at least 1
        high-power field (hpf)

        - Active symptomatic and histological EoE at baseline

        Major Exclusion Criteria:

          -  Clinically and endoscopically suspicion for gastroesophageal reflux disease,
             achalasia, or sklerodermia

          -  Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia

          -  Other clinical evident causes than EoE for esophageal eosinophilia

          -  Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac
             disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or
             fungal infection)

          -  Any relevant systemic disease (e.g., AIDS, active tuberculosis)

          -  Abnormal hepatic function at screening visit, liver cirrhosis, or portal hypertension

          -  Abnormal renal function at screening

          -  History of cancer in the last five years (except for non-metastatic cancers, e.g.,
             basalioma)

          -  History of esophageal surgery at any time or of esophageal dilation procedures within
             the last 8 weeks prior to screening visit

          -  Upper gastrointestinal bleeding within 8 weeks prior to screening visit

          -  Concomitant, or within the 4 weeks prior to screening visit, treatment with systemic
             therapies for any reason that may affect assessment of primary and secondary
             endpoints, i.e., systemic glucocorticoids, histamine antagonists, mast cell
             stabilizers, leukotriene receptor antagonists, biologics, or immunosuppressants

          -  Concomitant, or within the 2 weeks prior to screening visit, treatment with topical
             therapies for any reason that may affect assessment of primary and secondary
             endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate

          -  Installation of dietary restrictions within 4 weeks prior to screening visit or during
             treatment

          -  Intake of grapefruit containing food or beverages during the treatment with study
             medication

          -  Known intolerance/hypersensitivity to study drug

          -  Existing or intended pregnancy or breast-feeding