Double-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis

Phase 3

Completed

Conditions: oesophageal inflammation
10017966

Registration Number: NL-OMON47207

Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

- Signed informed consent,
- Male or female patients, 18 to 75 years of age,
- Confirmed clinico-pathological diagnosis of EoE according to established diagnostic criteria ,
- Clinico-pathological remission of EoE
- A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia,
- Negative pregnancy test in females of childbearing potential at baseline visit

Exclusion Criteria

- Clinical signs (i.e., acid regurgitation and/or heart burn) and/or endoscopic signs (at least Los Angeles Classification of Esophagitis Grade A) of gastroesophageal reflux disease (GERD),
- History of abnormal results in case of an optionally performed pH monitoring of the distal esophagus,
- Patients with PPI-responsive esophageal eosinophilia
- Achalasia, scleroderma esophagus, or systemic sclerosis,
- Other clinically 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 [candida esophagitis]),
- Any relevant systemic disease (e.g., AIDS, active tuberculosis),
- If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
- Liver cirrhosis or portal hypertension,
- 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,
- Existing or intended pregnancy or breast-feeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Rate of patients free of treatment failure after 48 weeks of treatment.<br /><br>Treatment failure after 48 weeks of treatment is yes, if at least one of the<br /><br>following criteria is met at any time during the DB treatment phase:<br /><br>- Clinical relapse, i.e., experiencing dysphagia or pain during swallowing in<br /><br>the past seven days (7-day recall period) of a severity of 4 points on a 010<br /><br>NRS for dysphagia or pain during swallowing, respectively, confirmed by a<br /><br>severity of 4 points on at least 1 day during the subsequent week on the<br /><br>respective 0 10 NRS for dysphagia or pain during swallowing (24-hours recall<br /><br>period).<br /><br>- Histological relapse, i.e., a peak of 48 eos/mm2 hpf at DB V6/EOT,<br /><br>- Experiencing a food impaction which needed endoscopic intervention,<br /><br>- Need for an endoscopic dilation,<br /><br>- Premature withdrawal for any reason.</p><br>

Secondary Outcome Measures