Eosinophilic EsophagitisPhase 2NCT05488405
Mesalazine Oral Suspension in Active Eosinophilic Esophagitis
A Phase 2 study testing Mesalamine Oral Product in people with Eosinophilic Esophagitis, run by Dr. Falk Pharma GmbH at 1 site in Switzerland.
Trial summary
Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Mesalamine Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Feb 2023to 20 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Male or female patients, 18 to 75 years of age
- Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
- Negative pregnancy test in females of childbearing potential
Who cannot join
- Other causes for esophageal eosinophilia
- Clinical and endoscopic signs of gastroesophageal reflux disease (GERD)
- 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 known or suspicion for relevant infectious diseases associated with clinical signs,
- Known intolerance/hypersensitivity/resistance to the IMP or excipients or drugs of similar chemical structure or pharmacological profile
- Existing or intended pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Monocentric Phase IIa Pilot Study Evaluating the Efficacy and Tolerability of a 4-week Treatment With Mesalazine Oral Suspension in Patients With Active Eosinophilic Esophagitis
Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis
Read the detailed description
This is an open-label, monocentric exploratory phase IIa pilot study, which serves to evaluate the efficacy, safety, and tolerability of treatment with mesalazine oral suspension for the treatment of active eosinophilic esophagitis (EoE).
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Mesalamine Oral Product
- Keywords
- Esophageal dysfunction, esophageal inflammation
- Medical subject headings
- Eosinophilic Esophagitis, Esophageal Diseases, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesalamine Oral ProductDrug
Also called 5-ASA
Mesalamine oral suspension for oral use
| Study group | Role | What they receive |
|---|---|---|
| Mesalamine treatment | Experimental | Treatment of patient with mesalamine oral suspension Receives: Drug: Mesalamine Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with histological remission
Assessment of remission of histological signs of EoE
Measured: 4 weeks
Secondary outcomes (2)
Proportion of patients with histological response
Assessment of improvement of histological signs of EoE
Measured: 4 weeks
Proportion of patients with improvement of symptoms
Clinical symptoms will be assessed via patient reported outcome measures.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start9 Feb 2023
- Primary completion30 Jun 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luc Biedermann, PD Dr. med., Principal investigator, UniversitätsSpital Zürich Klinik für Gastroenterologie und Hepatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488405
- Sponsor's protocol ID
- SAV-1/EEA
- Status last verified
- Sep 2023
- First submitted
- 3 Aug 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Monocentric Phase IIa Pilot Study Evaluating the Efficacy and Tolerability of a 4-week Treatment With Mesalazine Oral Suspension in Patients With Active Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT05488405
- Acronym / sponsor ID
- SAV-1/EEA
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Esophageal dysfunction, esophageal inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis
Detailed description
This is an open-label, monocentric exploratory phase IIa pilot study, which serves to evaluate the efficacy, safety, and tolerability of treatment with mesalazine oral suspension for the treatment of active eosinophilic esophagitis (EoE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesalamine treatment | Experimental | Drug: Mesalamine Oral ProductTreatment of patient with mesalamine oral suspension |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Male or female patients, 18 to 75 years of age
- Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
- Negative pregnancy test in females of childbearing potential
Key exclusion criteria (6 listed)
- Other causes for esophageal eosinophilia
- Clinical and endoscopic signs of gastroesophageal reflux disease (GERD)
- 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 known or suspicion for relevant infectious diseases associated with clinical signs,
- Known intolerance/hypersensitivity/resistance to the IMP or excipients or drugs of similar chemical structure or pharmacological profile
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesalamine Oral ProductAlso: 5-ASAMesalamine oral suspension for oral use | Drug | Mesalamine treatment |
Primary outcome
Proportion of patients with histological remission
Time frame: 4 weeks
Assessment of remission of histological signs of EoE
2 secondary outcomes
Proportion of patients with histological response
Time frame: 4 weeks
Proportion of patients with improvement of symptoms
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Biedermann, PD Dr. med. principal investigator
UniversitätsSpital Zürich Klinik für Gastroenterologie und Hepatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesalamine Oral Product in people with Eosinophilic Esophagitis, run by Dr. Falk Pharma GmbH at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with histological remission (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.