Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults' Subjects of Both Genders With Eosinophilic Esophagitis (EoE) (BESIDE)

August 22, 2024 updated by: Bazell Pharma AG

A Phase I/II, Multicenter, Double-blind, Parallel, Randomized Trial to Assess Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults Subjects of Both Genders With Eosinophilic Esophagitis (EoE)

A phase I/II, multicenter, double-blind, parallel, randomized trial to assess pharmacokinetics, efficacy, tolerability and safety of different budesonide oral gel doses in adults subjects of both genders with eosinophilic esophagitis (EoE)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects able to read, understand and sign the Informed Consent Form (ICF) approved by Ethical Committee;
  • Male and female subjects aged between 18 and 75 years old;
  • Body weight between 60-100 kg;
  • Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2;
  • Non-childbearing potential female subjects. Childbearing potential is defined as: post-menopausal women (defined as 12 months of amenorrhea or more), hysterectomized women, oophorectomized (bilateral) women and/or those who underwent tubal ligation;
  • Female participants of childbearing potential who test negative for the pregnancy test on the day of administration of the first dose of the drug (Visit 1), as well as throughout the clinical trial;
  • Female participants who practice adequate contraception or who abstain from all activities that could result in pregnancy for at least 28 days before administering the first dose of the drug (Visit 1);
  • Female participants who agree to continue adequate contraception for 1 month after administration of the last dose of the investigational drug;
  • Participants diagnosed with EoE, verified from a combination of symptoms compatible with EoE and histological finding greater than 15 eosinophils per high-power field in at least one esophageal mucosal biopsy;
  • Participants unresponsive to stable dose of proton-pump inhibitor (PPI).

Exclusion Criteria:

  • Subjects with a malignancy history within the last 5 years, except from successfully treated basal cell carcinoma;
  • History of esophageal stenosis requiring dilation and/or stenosis at endoscopy not allowing to pass the endoscope;
  • Subjects with a eosinophilic gastroenteritis diagnosis (presence of eosinophilic infiltrate in gastric antrum and duodenum);
  • Subjects with a reflux esophagitis history;
  • Subject with a previous serious asthma diagnosis;
  • Subjects with a gastroesophageal tract disease that, at the investigator's discretion, is deemed as an obstacle to take part in the trial;
  • People with chronic diseases on regular drugs that, in the investigator's opinion, may interfere with the trial;
  • Medical conditions such as serious heart or lung diseases preventing the safe performance of endoscopy;
  • Subjects with conditions known to be related to esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia and hypereosinophilic syndrome;
  • Subjects who have been on oral, intranasal or systemic corticosteroid at least 15 days prior to trial start;
  • Smoker of having quit smoking less than 6 months ago;
  • Have a history of excessive alcohol intake for at least 6 months prior to trial start (intake of 5 or more alcoholic beverages in one day or 15 or more alcoholic beverages per week);
  • Subjects having 5 or more cups of tea or coffee per day and who cannot abstain from them for the trial period;
  • Be on CYP3A4 inhibitors, such as ketoconazole and grapefruit juice;
  • Electrocardiogram (ECG) findings that, in the investigator's opinion, may jeopardize participation in the trial;
  • History or presence of gastrointestinal or liver disease or other condition interfering with drug absorption, distribution, excretion or metabolism;
  • Subjects with hypersensitivity or contraindication of using any formulation components;
  • Subjects who have been part of trial protocols in the last 12 (twelve) months (CNS Resolution 251, dated August 7, 1997, item III, sub-item J);
  • Have donated blood (> 500 mL) or undergone major surgery within the 3 months prior to the ICF signature date;
  • Have been vaccinated for the 30 days prior to admission;
  • Clinical evidence of infectious process potentially contributing for dysphagia (candidiasis, cytomegalovirus (CMV), herpes);
  • Other dysphagia cause identified at endoscopy (peptic stenosis, web, ring, achalasia, esophageal neoplasm);
  • Breastfeeding subjects, who plan to become pregnant or with a positive pregnancy test during the trial;
  • Any medical condition or laboratory change that, in the investigator's opinion, may jeopardize participation in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Low dose
Drug: Budesonide Gel
Twice daily regimen
Experimental: Group 2
Middle dose
Drug: Budesonide Gel
Twice daily regimen
Experimental: Group 3
High dose
Drug: Budesonide Gel
Twice daily regimen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determination of Pharmacokinetic Profiles
Time Frame: First 24 hours after a single drug dose administration
Peak Plasma Concentration (Cmax)
First 24 hours after a single drug dose administration
Determination of Pharmacokinetic Profiles
Time Frame: First 24 hours after a single drug dose administration
Area under the plasma concentration versus time curve (AUC)
First 24 hours after a single drug dose administration
Determination of Pharmacokinetic Profiles
Time Frame: First 24 hours after a single drug dose administration
Half-life (T1/2)
First 24 hours after a single drug dose administration
Determination of Pharmacokinetic Profiles
Time Frame: First 24 hours after a single drug dose administration
Oral clearance (CL/F)
First 24 hours after a single drug dose administration
Proportion of subjects reaching a histological response
Time Frame: 8 weeks of treatment
≤ 6 eosinophils per high power field
8 weeks of treatment
Improvement in dysphagia symptoms consistent with the disease
Time Frame: 8 weeks of treatment
EAT (Eating Assessment Tool) -10 questionnaire
8 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of non-serious and serious adverse events rate
Time Frame: Through 8 weeks
Through 8 weeks
Quality of life assessment of subjects
Time Frame: Through 8 weeks
WHOQOL-bref questionnaire
Through 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bazell Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BAZ006-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data (IPD) available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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