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Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by University of Tennessee.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT02371941
First received: February 11, 2015
Last updated: March 11, 2015
Last verified: March 2015
  Purpose
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.

Condition Intervention Phase
Eosinophilic Esophagitis Drug: oral cromolyn sodium Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study of the Use of Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Peak esophageal eosinophil count [ Time Frame: 2 months ]
    Measure of the peak esophageal eosinophil count on esophageal biopsy specimens after 2 months of therapy


Secondary Outcome Measures:
  • Symptoms as measured by Pediatric Eosinophilic Esophagitis Symptom Score [ Time Frame: 1 month and 2 month ]
    Symptom scores will be measures at baseline, 1 month, and 2 months using a symptom scoring assessment tool known as the Pediatric Eosinophilic Esophagitis Symptom Score.


Estimated Enrollment: 24
Study Start Date: December 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral cromolyn

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
Oral cromolyn sodium
Other Name: Gastrocrom
Placebo Comparator: Placebo
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
Saline

Detailed Description:

Eosinophilic esophagitis is an antigen-mediated allergic disease of the esophagus characterized by symptoms of gastrointestinal complaints and eosinophilic inflammation limited to the esophagus. Currently, first line therapeutic recommendations include swallowed, topical steroids or dietary therapy. While both work for the majority of patients, they both have limitations.

The investigators are examining the use of oral cromolyn sodium as a treatment for this condition. This medication is a non-steroid that is already approved for other conditions. When taken orally, it is essentially not absorbed systemically, so side effects are minimal. There is only 1 brief, retrospective report of its use in this condition suggesting it does not work. However, from studying swallowed, topical steroids, it may require formulating the medication into a viscous preparation for it to work.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of eosinophilic esophagitis

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02371941

Contacts
Contact: Jay A Lieberman, MD 9012875283 jlieber1@uthsc.edu

Locations
United States, Tennessee
LeBonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Jay A Lieberman, MD    901-287-5283    jlieber1@uthsc.edu   
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Jay A Lieberman, MD The University of Tennessee Health Science Center
  More Information

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02371941     History of Changes
Other Study ID Numbers: 13-02521-FB
Study First Received: February 11, 2015
Last Updated: March 11, 2015

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cromolyn Sodium
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 21, 2017