Antihistamines in Eosinophilic Esophagitis

NCT04248712 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 19-005510
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are assessing the safety and effectiveness of antihistamines in the treatment of eosinophilic esophagitis.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Number of adverse events reported

  12 weeks

• Change in Maximum Eosinophil Count

  Calculated by maximum eosinophils per esophagogastroduodenoscopy (EGD) high-power field (eos/hpf) after therapy with antihistamines. As measured by the percentage of change in maximum eosinophil count from baseline to 12 weeks.

  12 weeks

Secondary Outcomes (3)

• Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire

  12 weeks

• Change in Endoscopic Response, as Measured by the Endoscopic Reference Score

  12 weeks

• Change in Histologic Response

  12 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.

Drug: Famotidine; Drug: Loratadine

Placebo Group

PLACEBO COMPARATOR

Participants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks.

Drug: Placebo

Interventions

Famotidine DRUG

40 mg tab twice daily by mouth for 12 week duration

Treatment Group

Loratadine DRUG

10 mg tab once daily by mouth for 12 week duration

Treatment Group

Placebo DRUG

Contains no active ingredient

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18, male and female.
• Patients who carry the diagnosis of Eosinophilic Esophagitis (EoE) based on esophageal biopsies obtained within 6 months prior to enrollment (\>15 eosinophils per hpf on at least 2 esophageal levels)
• Subjects must be able to give appropriate informed consent

You may not qualify if:

• Not willing or able to sign consent.
• Patients who have used topical or systemic corticosteroid therapy for any reason in the previous 6 weeks.
• Patients who have been treated with acid-suppressing medications (PPI or H2 receptor antagonists) in the previous 6 weeks.
• Patients on immunosuppressive or immunomodulating medications in the previous 6 weeks.
• Patients with known allergies or hypersensitivity to anti-histamines.
• Patients who have contraindications to the procurement of esophageal biopsies including patients who have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel.
• Patients who have a contraindication to the performance of an esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an endoscopic procedure.
• Patients who are pregnant.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Famotidine; Loratadine

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Polycyclic Compounds

Limitations and Caveats

Terminated study due to low enrollment. No subjects enrolled in the Placebo group

Results Point of Contact

• Title: Dawn Francis, M.D.
• Organization: Mayo Clinic

Francis.Dawn@mayo.edu

904-953-2254

Study Officials

• Dawn Francis, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: July 10, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 20, 2022
• Results First Posted: December 20, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)