NCT02371941

Brief Summary

This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when made into a viscous preparation for the treatment of eosinophilic esophagitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

February 11, 2015

Results QC Date

April 22, 2019

Last Update Submit

October 24, 2023

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

  • Peak Esophageal Eosinophil Count

    Measure of the peak esophageal eosinophil count on esophageal biopsy specimens after 2 months of therapy

    2 months

Secondary Outcomes (1)

  • Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score

    Baseline as compared to 2 months

Study Arms (2)

Oral cromolyn

EXPERIMENTAL

Subjects randomized to the experimental arm will receive oral cromolyn sodium. The dose will be per current package insert for oral cromolyn: Subjects 2-12 years of age - 100 mg (1 ampule) 4 times daily Subjects 13-18 years of age - 200 mg (2 ampules) 4 times daily

Drug: oral cromolyn sodium

Placebo

PLACEBO COMPARATOR

Subjects randomized to placebo will receive normal saline ampules Subjects 2-12 years of age - 1 ampule 4 times daily Subjects 13-18 years of age - 2 ampules 4 times daily

Drug: Placebo

Interventions

oral cromolyn sodiumDRUG

Oral cromolyn sodium

Also known as: Gastrocrom
Oral cromolyn
PlaceboDRUG

Saline

Placebo

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of eosinophilic esophagitis

You may not qualify if:

  • Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed corticosteroids will require a 4 week washout period.
  • Pregnancy (all females of child bearing potential will have urine pregnancy test done at baseline).
  • Evidence of pathologic eosinophilia in other locations in the GI tract.
  • Participation in another research protocol
  • Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and liver function panel drawn)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LeBonheur Children's Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • Lieberman JA, Zhang J, Whitworth J, Cavender C. A randomized, double-blinded, placebo-controlled study of the use of viscous oral cromolyn sodium for the treatment of eosinophilic esophagitis. Ann Allergy Asthma Immunol. 2018 May;120(5):527-531. doi: 10.1016/j.anai.2018.03.006. Epub 2018 Mar 12.

    PMID: 29544738DERIVED

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Cromolyn Sodium

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr. Jay Lieberman
Organization
The University of Tennessee Health Science Center
jlieber1@uthsc.edu
901-287-7337

Study Officials

  • Jay A Lieberman, MD

    The University of Tennessee Health Science Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2015

First Posted

February 26, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

October 26, 2023

Results First Posted

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)