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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 November 2023 |
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Main ID: |
NCT02371941 |
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Date of registration:
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11/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled Study of the Use of Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02371941 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Jay A Lieberman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Tennessee Health Science Center |
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Key inclusion & exclusion criteria
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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)
Age minimum:
2 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Eosinophilic Esophagitis
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Intervention(s)
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Drug: Placebo
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Drug: oral cromolyn sodium
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Primary Outcome(s)
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Peak Esophageal Eosinophil Count
[Time Frame: 2 months]
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Secondary Outcome(s)
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Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score
[Time Frame: Baseline as compared to 2 months]
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Secondary ID(s)
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13-02521-FB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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