Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD

NCT01808196 | Completed Phase 2 Results DMC

• 1 other identifier: 2012-0106
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eosinophilic Esophagitis; Connective Tissue Disorders

Keywords

Eosinophilic Esophagitis; Connective Tissue Disorders; Drug trial

Outcome Measures

Primary Outcomes (1)

• 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

  16 weeks after treatment

Secondary Outcomes (2)

• Change in Peak Eosinophil Count at 16 Weeks

  Baseline, 16 weeks after treatment

• Change in Pediatric EoE Symptom Score at 16 Weeks

  Baseline, 16 weeks after treatment

Study Arms (1)

Losartan

EXPERIMENTAL

Participants with eosinophilic esophagitis receive Losartan daily

Drug: Losartan Potassium

Interventions

Losartan Potassium DRUG

The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.

Also known as: Angiotensin II Receptor Antagonists

Losartan

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Kara Kliewer

Mason, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Connective Tissue Diseases

Interventions

Losartan; Angiotensin Receptor Antagonists

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Pablo Abonia, MD
• Organization: Cincinnati Children's Hospital Medical Center

pablo.abonia@cchmc.org

513-636-

Study Officials

• J. Pablo Abonia, M.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Marc E Rothenberg, M.D., Ph.D.

  Children's Hospital Medical Center, Cincinnati

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is an open-label study which means that all participants receive the study medicine

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: March 11, 2013
• Study Start: October 10, 2013
• Primary Completion: January 13, 2015
• Study Completion: February 13, 2015
• Last Updated: September 24, 2020
• Results First Posted: September 24, 2020

Record last verified: 2020-08

Locations

US (1)