A study to investigate the efficacy and tolerance of budesonide tablets and suspension in patients suffering from esophagitis over a 14 day period

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2009-016692-29-BE
• Date of registration: 24/11/2011
• Prospective Registration: Yes
• Primary sponsor: Dr. Falk Pharma GmbH
• Public title: A study to investigate the efficacy and tolerance of budesonide tablets and suspension in patients suffering from esophagitis over a 14 day period
• Scientific title: Double-blind, double-dummy, randomized, placebo-controlled, phase IIa study on the efficacy and tolerability of a 14-day treatment with budesonide effervescent tablets vs. viscous budesonide suspension vs. placebo in patients with eosinophilic esophagitis - Budesonide effervescent tablets vs. viscous budesonide suspension vs. placebo in EE
• Date of first enrolment: 20/02/2012
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016692-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Double-dummy If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Germany, Switzerland

Contacts

• Name: Project Management
• Affiliation: Aptiv Solutions GmbH

• Name: Project Management
• Affiliation: Aptiv Solutions GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed informed consent,
2. Male or female patients, 18 to 75 years of age,
3. Confirmed clinicopathological diagnosis of EoE according to established diagnostic criteria
4. Active symptomatic and histological EoE
5. Negative pregnancy test in females of childbearing potential at screening visit 2,
6. Women of child-bearing potential have to apply during the entire duration of the study a highly effective method of birth control

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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
1. Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia,
2. Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia,
3. Other clinical evident causes than EoE for esophageal eosinophilia,
4. Any concomitant esophageal disease and relevant gastro-intestinal disease,
5. Abnormal hepatic function, liver cirrhosis, or portal hypertension,
6. Abnormal renal function,
7. History of cancer in the last five years (except for non-metastatic
cancers, e.g., basalioma),
8. History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit 2,
9. Upper gastrointestinal bleeding within 8 weeks prior to screening visit 2,
10. Concomitant, or within the 4 weeks prior to screening visit 2, 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,
11. Concomitant, or within the 2 weeks prior to screening visit 2, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate,
12. Installation of dietary restrictions within 4 weeks prior to screening visit 2 or during treatment,
13. Intake of grapefruit containing food or beverages during the treatment with study medication,
14. Known intolerance/hypersensitivity to study drug,
15. History of intolerance/hypersensitivity to propofol, soja or soja oil, saturated triglycerides, lecithin, egg or egg derivatives, if propofol will be used for sedation during endoscopy,
16. Existing or intended pregnancy or breast-feeding,


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Active eosinophilic esophagitis
MedDRA version: 14.1 Level: LLT Classification code 10064220 Term: Eosinophilic esophagitis System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: 1mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Current Sponsor code: BUET 1 mg
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Orodispersible tablet
Route of administration of the placebo: Oral use

Product Name: 2mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 2mg
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Current Sponsor code: BUET 2 mg
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Orodispersible tablet
Route of administration of the placebo: Oral use

Product Name: Budesonide [0.4mg/ml] viscous suspension
Product Code: BUU 0.4mg/ml
Pharmaceutical Form: Oral suspension
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Current Sponsor code: BUU: Budesonide viscous suspension
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.4-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: • To study safety and tolerability in the form of adverse events and laboratory parameters,
• To assess patients’ quality of life,
• To assess the patient's acceptance and preference of the study drugs.

Primary end point(s): Primary efficacy endpoint:
Rate of histological remission at week 2 (LOCF)

Co-primary efficacy endpoint:
Change in the mean numbers of eos/mm2 hpf (eosinophil load) from baseline to week 2 (LOCF)

Timepoint(s) of evaluation of this end point: week 2

Main Objective: To assess the efficacy of 2x1 mg/d or 2x2 mg/d budesonide effervescent tablets vs. 2x2 mg/d oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: week 2

Secondary end point(s): Secondary efficacy endpoints:
• Rate of histological response at week 2 (LOCF),
• Change in the Dysphagia Score,
• Adverse events

Secondary ID(s)

BUU-2/EEA

Source(s) of Monetary Support

Dr. Falk Pharma GmbH