A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01458418
• Date of registration: 18/10/2011
• Prospective Registration: Yes
• Primary sponsor: Children's Mercy Hospital Kansas City
• Public title: A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children
• Scientific title: A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children
• Date of first enrolment: December 2011
• Target sample size: 4
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01458418
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Stephanie Page, MD
• Affiliation: Children's Mercy Hospital Kansas City

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and females aged 2-17

- Presence of more than 15 eosinophils per hpf on original endoscopy and less than 5
eosinophils/hpf on the most recent endoscopy

- Concurrent PPI for 1 month at 1-2mg/kg/dose prior to endoscopy or have a negative pH
study

- English speaking

- Ability to undergo a follow up endoscopy between 12 and 13 weeks after the start of
the study

- Procurement of written informed consent signed by the subject's legal guardian and
study investigator (s) and subject assent.

Exclusion Criteria:

- Subjects with eosinophils in stomach and duodenum on original endoscopy.

- Subjects requiring oral prednisone within 1 month of current endoscopy.

- Subjects with diagnosis of other co-morbid diseases such as heart disease, renal
disease, autoimmune disease, an immunodeficiency, diabetes, phenylketonuria, or
thyroid disease.

- Subjects using Montelukast within one month of current endoscopy

- Subjects with concurrent use of phenobarbital or rifampin



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Drug: Montelukast

Other: placebo

Drug: 5 mg Montelukast

Primary Outcome(s)

Eosinophil Count [Time Frame: 12 weeks]

Secondary ID(s)

CMH 11 01-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01458418