Eosinophilic EsophagitisPhase 4NCT02371941
Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
A Phase 4 study testing oral cromolyn sodium in people with Eosinophilic Esophagitis, run by University of Tennessee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- oral cromolyn sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of eosinophilic esophagitis
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
LeBonheur Children's Hospital
Memphis, Tennessee, 38105
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Use of Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
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.
Read the 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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- oral cromolyn sodium, Placebo
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral cromolyn sodiumDrug
Also called Gastrocrom
Oral cromolyn sodium
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Esophageal Eosinophil Count
Measure of the peak esophageal eosinophil count on esophageal biopsy specimens after 2 months of therapy
Measured: 2 months
Secondary outcomes (1)
Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score
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 (PEESS).
The PEESS is a validated symptom score that is completed by the parent of the patient.
It encompasses frequency and severity of EoE related symptoms over the past month.
The minimum score = 0. The max score = 98 The higher the score/value, the more severe and/or frequent the symptoms and therefore a worse outcome.
Measured: Baseline as compared to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay A Lieberman, MD, Principal investigator, The University of Tennessee Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371941
- Sponsor's protocol ID
- 13-02521-FB
- Status last verified
- Oct 2023
- First submitted
- 11 Feb 2015
- Last updated
- 26 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29544738
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of the Use of Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT02371941
- Acronym / sponsor ID
- 13-02521-FB
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Posted 26 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral cromolyn | Experimental | Drug: oral cromolyn sodiumSubjects 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 |
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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 |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Diagnosis of eosinophilic esophagitis
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral cromolyn sodiumAlso: GastrocromOral cromolyn sodium | Drug | Oral cromolyn |
| PlaceboSaline | Drug | Placebo |
Primary outcome
Peak Esophageal Eosinophil Count
Time frame: 2 months
Measure of the peak esophageal eosinophil count on esophageal biopsy specimens after 2 months of therapy
1 secondary outcome
Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score
Time frame: Baseline as compared to 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29544738Lieberman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay A Lieberman, MD principal investigator
The University of Tennessee Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral cromolyn sodium in people with Eosinophilic Esophagitis, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Esophageal Eosinophil Count (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.