Prevention of oesophageal strictures in adult patients after endoscopic submucosal dissection MedDRA version: 25.1 Level: LLT Classification code 10030186 Term: Oesophageal squamous cell carcinoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10030137 Term: Oesophageal adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR
Conditions
Interventions
Trade Name: Jorveza 1 mg orodispersible tablets
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent; • Male or female patients, 18 to 85 years of age; • Estimated life expectancy of at least one year (not applicable in Portugal); • ECOG Performance Status of = 2 at the randomisation visit (i.e. after the ESD-procedure); • a) Biopsy proven or endoscopically suspect oesophageal SCC and/or high grade dysplasia in a focal lesion of the squamous epithelium, treated with ESD; or b) Biopsy proven or endoscopically suspect BE-HGD or EAC, treated with ESD; • Mucosal defect after ESD of a) = 50% oesophageal circumference in a patient with SCC, or b) = 75% oesophageal circumference in a patient with BE-HGD or EAC; • Negative pregnancy test in females of childbearing potential at the screening visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: •Any prior or intended chemotherapy for oesophageal cancer; • Any prior ESD in the area where ESD will be done; • Any prior or intended oesophageal surgery or surgery for the mediastinum, endoscopic mucosal resection (EMR), or radio frequency ablation (RFA), in the area where ESD will be done; • Evidence of regional lymph node metastases or distant metastases prior to ESD; • Any prior or intended radiotherapy which involves or affects the area of ESD during the last 5 years; •Any prior endoscopic dilation for oesophageal stenosis which involves or affects the area of ESD during the last 5 years; • Any other concomitant oesophageal disease; •Any severe concomitant disease, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results, or any disorder which in the opinion of the investigator might affect the patient's safety; • Any systemic therapy for any reason that may affect assessment of primary or secondary endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the efficacy of eight weeks treatment with 2 x 1 mg/day or 2 x 2 mg/day budesonide orodispersible tablets vs. placebo for prevention of oesophageal strictures after endoscopic submucosal dissection.;Secondary Objective: • To study safety and tolerability of budesonide orodispersible tablets vs. placebo by means of adverse events and laboratory parameters. • To assess patients’ quality of life. ;Primary end point(s): Primary efficacy endpoint: • Percentage of patients free of strictures at visit week 8.;Timepoint(s) of evaluation of this end point: after 8 weeks of double-blind phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: • Number of endoscopic dilations per patient during the DB treatment phase. • Percentage of patients free of strictures until the FU visit.;Timepoint(s) of evaluation of this end point: Endpoint 'Number of endoscopic dilations per patient during the DB treatment phase': after 8 weeks of double-blind phase Endpoint 'Percentage of patients free of strictures until the FU visit': at follow-up visit | — |
Countries
Belgium, Germany, Netherlands, Poland, Portugal, Sweden
Contacts
Public ContactDept. of Clin. Res. & Development
Dr. Falk Pharma GmbH
Outcome results
None listed