Eosinophilic EsophagitisPhase 2NCT01808196
Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD
A Phase 2 study testing Losartan Potassium in people with Eosinophilic Esophagitis and Connective Tissue Disorders, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to test the safety of losartan potassium and see what effects (good and bad) it has on you and your eosinophilic esophagitis. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Eosinophilic Esophagitis, Connective Tissue Disorders
- What is being tested?
- Losartan Potassium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2013to 13 Feb 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed diagnosis of eosinophilic esophagitis.
- Have been on a high dose proton pump inhibitor for at least 8 weeks prior to a diagnostic endoscopy of eosinophilic esophagitis without histologic resolution.
- Agree to maintain the same diet throughout the duration of the study.
- If participant is female: meet one of the following criteria:
- Is of non-childbearing potential (pre-menarchal or surgically sterile with documentation)
- Is of childbearing potential with a negative urine pregnancy test at screening.
Who cannot join
- Past or planned cardiac surgeries.
- Had an aortic root Z-score greater than 3 on a previous echocardiogram.
- Have intolerance to the study agent such as angioedema, IgE-mediated allergy.
- Have renal dysfunction with creatinine in excess of the upper normal limit for age.
- Have another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome, Churg Strauss vasculitis, eosinophilic granuloma, or a parasitic infection).
- Diagnosed with hepatic insufficiency.
Show all 18Show fewer
- History of abnormal gastric or duodenal biopsy or documented gastrointestinal (GI) disorders (e.g., Celiac Disease, Crohn's disease or helicobacter pylori infection.), not including chronic gastritis, chronic duodenitis, mucosal eosinophilia or other eosinophilic gastrointestinal disorders.
- Used anti-immunoglobulin E [IgE] mAb, anti-tumor necrosis factor [TNF] mAb, anti-IL-5 agents, or anti-IL-13 within the last six months.
- Used methotrexate, cyclosporine, interferon-α, or other systemic immunosuppressive or immunomodulating agents within the last three months.
- Have a history of a stricture during an endoscopy procedure that prevents passage of the endoscope.
- Taking or plan to take an angiotensin II receptor blocker (ARB) therapy, angiotensin-converting enzyme inhibitor (ACEI), beta blocker therapy (BB), or calcium channel blocker at the screening visit or at any time during the study, or have you been taking any of these medications for the last three months.
- If the participant is female: pregnant or nursing.
- Taking any investigative drug or device study within the last 30 days.
- Had participated in any investigative biologics study within the last three months prior to the study entry.
- Taking or plan to take hydrochlorothiazide, warfarin, cimetidine, phenobarbital, rifampin, or fluconazole.
- If the participant is female: using a medically accepted effective method of birth control.
- Will be able to complete all study procedures including endoscopy.
- Taking or plan to take potassium supplements or salt substitutes containing potassium.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Preliminary, Open-label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder.
The purpose of this research study is to test the safety of losartan potassium and see what effects (good and bad) it has on you and your eosinophilic esophagitis.
Read the detailed description
Losartan is a drug that is approved by the United States Food and Drug Administration (FDA) for use in adults and children over 6 years of age who have high blood pressure. Losartan has been safe when administered to patients with normal blood pressure. This medication has not been studied in people with eosinophilic esophagitis or connective tissue disorder. Eosinophils are a type of white blood cell that induces inflammation. Eosinophils with other inflammatory cells produce a protein called TGF-β, which may contribute to part of EoE. Losartan may reduce the amount of this protein and therefore, be a treatment for eosinophilic esophagitis.
You will be in the research study for approximately 4 months. Participation in this research study will involve 9 study visits. Of the 9 study visits, at least 3 visits will take place in the clinic; the other visits may take place over the telephone.
Throughout the study, the following activities will occur:
- A physical and vital signs will be obtained
- There will be two endoscopies performed one at the beginning and one at the end of the study
- Blood will be obtained up to three times
- Pregnancy tests will be performed
- Quality-of-life questionnaires will be completed
This is an open-label trial, which means that if you choose to enroll and you meet screening criteria, you will receive Losartan as a treatment. You will start the study drug at a low dose. It will be increased at vist 3 the 1 month visit. The dose of study drug will be increased depending on your weight and how well you tolerate each dose but will not exceed 100mg of study drug per day. It may be increased or decreased during the study if there are any side effects. If you do not have certain side effects, you will take each dose of the study drug between 21 and 28 days until your next study visit. You will swallow a pill or liquid once or twice a day.
This study will consist of 4 phases: screening, treatment (titration and maintenance), end of treatment, and follow-up. Participants that are between 5 to 18 years of age, as well as the parent or legal guardian will be asked to complete questionnaires of quality-of-life symptom severity questionnaires. Participants between the age of 19 and 21 will also have to fill out these questionnaires, but parents/guardians will not have to fill these out. If you are the parent or caretaker, the only study activity in which you will be involved is the completion of questionnaires about you and your family.
- Being tested
- Losartan Potassium
- Keywords
- Eosinophilic Esophagitis, Connective Tissue Disorders, Drug trial
- Medical subject headings
- Eosinophilic Esophagitis, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan PotassiumDrug
Also called Angiotensin II Receptor Antagonists
The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | Participants with eosinophilic esophagitis receive Losartan daily Receives: Drug: Losartan Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants in Histologic Remission at 16 Weeks
Percent of participants with peak eosinophil count < 15 eosinophils/high power field (remission) in distal and proximal esophagus
Measured: 16 weeks after treatment
Secondary outcomes (2)
Change in Peak Eosinophil Count at 16 Weeks
Mean change in peak eosinophil count from baseline
Measured: Baseline, 16 weeks after treatment
Change in Pediatric EoE Symptom Score at 16 Weeks
The PEESS V2.0 questionnaire captures EoE-specific symptoms (dysphagia, GERD, nausea/vomiting, and pain) as reported by parents. The range for PEESS v2.0 scores is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. Scores were obtained at baseline and 16 weeks. Change in score is defined as total score at 16 weeks minus total score at baseline.
Measured: Baseline, 16 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study start10 Oct 2013
- Primary completion13 Jan 2015
- Study completion13 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Model description
- This study is an open-label study which means that all participants receive the study medicine
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Pablo Abonia, M.D., Principal investigator, Children's Hospital Medical Center, CincinnatiMarc E Rothenberg, M.D., Ph.D., Study director, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808196
- Sponsor's protocol ID
- 2012-0106
- Status last verified
- Aug 2020
- First submitted
- 30 Jan 2013
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary, Open-label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder.
- ClinicalTrials.gov ID
- NCT01808196
- Acronym / sponsor ID
- 2012-0106
- Keywords
- Eosinophilic Esophagitis, Connective Tissue Disorders, Drug trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 10 Oct 2013 (actual)
- Primary completion
- 13 Jan 2015 (actual)
- Study completion
- 13 Feb 2015 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the safety of losartan potassium and see what effects (good and bad) it has on you and your eosinophilic esophagitis.
Detailed description
Losartan is a drug that is approved by the United States Food and Drug Administration (FDA) for use in adults and children over 6 years of age who have high blood pressure. Losartan has been safe when administered to patients with normal blood pressure. This medication has not been studied in people with eosinophilic esophagitis or connective tissue disorder. Eosinophils are a type of white blood cell that induces inflammation. Eosinophils with other inflammatory cells produce a protein called TGF-β, which may contribute to part of EoE. Losartan may reduce the amount of this protein and therefore, be a treatment for eosinophilic esophagitis.
You will be in the research study for approximately 4 months. Participation in this research study will involve 9 study visits. Of the 9 study visits, at least 3 visits will take place in the clinic; the other visits may take place over the telephone.
Throughout the study, the following activities will occur:
- A physical and vital signs will be obtained
- There will be two endoscopies performed one at the beginning and one at the end of the study
- Blood will be obtained up to three times
- Pregnancy tests will be performed
- Quality-of-life questionnaires will be completed
This is an open-label trial, which means that if you choose to enroll and you meet screening criteria, you will receive Losartan as a treatment. You will start the study drug at a low dose. It will be increased at vist 3 the 1 month visit. The dose of study drug will be increased depending on your weight and how well you tolerate each dose but will not exceed 100mg of study drug per day. It may be increased or decreased during the study if there are any side effects. If you do not have certain side effects, you will take each dose of the study drug between 21 and 28 days until your next study visit. You will swallow a pill or liquid once or twice a day.
This study will consist of 4 phases: screening, treatment (titration and maintenance), end of treatment, and follow-up. Participants that are between 5 to 18 years of age, as well as the parent or legal guardian will be asked to complete questionnaires of quality-of-life symptom severity questionnaires. Participants between the age of 19 and 21 will also have to fill out these questionnaires, but parents/guardians will not have to fill these out. If you are the parent or caretaker, the only study activity in which you will be involved is the completion of questionnaires about you and your family.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is an open-label study which means that all participants receive the study medicine
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: Losartan PotassiumParticipants with eosinophilic esophagitis receive Losartan daily |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of eosinophilic esophagitis.
- Have been on a high dose proton pump inhibitor for at least 8 weeks prior to a diagnostic endoscopy of eosinophilic esophagitis without histologic resolution.
- Agree to maintain the same diet throughout the duration of the study.
- If participant is female: meet one of the following criteria:
Key exclusion criteria (18 listed)
- Past or planned cardiac surgeries.
- Had an aortic root Z-score greater than 3 on a previous echocardiogram.
- Have intolerance to the study agent such as angioedema, IgE-mediated allergy.
- Have renal dysfunction with creatinine in excess of the upper normal limit for age.
- Have another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome, Churg Strauss vasculitis, eosinophilic granuloma, or a parasitic infection).
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 |
|---|---|---|
| Losartan PotassiumAlso: Angiotensin II Receptor AntagonistsThe dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg. | Drug | Losartan |
Primary outcome
Percent of Participants in Histologic Remission at 16 Weeks
Time frame: 16 weeks after treatment
Percent of participants with peak eosinophil count < 15 eosinophils/high power field (remission) in distal and proximal esophagus
2 secondary outcomes
Change in Peak Eosinophil Count at 16 Weeks
Time frame: Baseline, 16 weeks after treatment
Change in Pediatric EoE Symptom Score at 16 Weeks
Time frame: Baseline, 16 weeks after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
J. Pablo Abonia, M.D. principal investigator
Children's Hospital Medical Center, Cincinnati
Marc E Rothenberg, M.D., Ph.D. study director
Children's Hospital Medical Center, Cincinnati
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 Losartan Potassium in people with Eosinophilic Esophagitis and Connective Tissue Disorders, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 6 inclusion and 18 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 24 Sep 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Participants in Histologic Remission at 16 Weeks (time frame: 16 weeks after treatment). 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 24 Sep 2020.