Functional Dyspepsia (FD) - Clinical Response to Montelukast in Children

Dyspepsia Clinical Trial

Official title:

Predictors of Clinical Response to Montelukast in Children With Functional Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360696
• Other study ID #: 13100348
• Status: Completed
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: May 2019
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Duodenal eosinophilia has been associated with dyspepsia in adults and the investigators have previously described the finding of duodenal mucosal eosinophilia in 71-79% of children undergoing diagnostic endoscopy. Previous studies in children have shown positive response to montelukast with approximately 50% finding complete relief and 20-30 percent showing no response.

There are a number of factors that have the potential to contribute to the observed variability in response to montelukast. These include variability in:

1. systemic drug exposure (drug absorption, biotransformation and/or elimination)

2. regulation of leukotriene biosynthesis

3. cysteinyl leukotriene receptors and downstream mediators

4. patient disease phenotype (e.g. Functional Gastrointestinal Disorder (FGID) disease classification, psychologic profile)

In this study, the investigators propose to utilize biopsy specimens stratified by drug response to identify candidate gene expression modules that will be validated in a prospective study design. The overall goal of this program is to develop a signature of montelukast response that can be applied not only to eosinophilic gastroenteritis, but more generally to other diseases, such as asthma, where the drug is widely used with variable success.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• Ages 8 - 17 years, inclusive

• Abdominal pain of at least 8 weeks duration and fulfilling symptom- based criteria for functional dyspepsia

• Scheduled for endoscopy following failure to respond to acid-reduction therapy

• Evidence of written parental permission (consent) and subject assent

Exclusion Criteria:

• Previous treatment with montelukast

• Treatment with corticosteroids or oral cromolyn sodium in the four weeks prior to enrollment

• Prior history or clinical signs/symptoms of chronic disease requiring regular medical care (e.g., diabetes mellitus, juvenile idiopathic arthritis, cystic fibrosis or cancer)

• Exposure within the past two weeks to drugs or natural products that induce CYP2C8/9 or CYP3A4, including amprenavir, carbamazepine, lopinavir/ritonavir, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenytoin, rifampin, St. John's Wort, or that inhibit CYP2C8/9 or CYP3A4, such as ciprofloxacin, clarithromycin, erythromycin, fluconazole, fluvoxamine, grapefruit juice, paroxetine, sertraline, sulfamethoxazole, trimethoprim

• A Body Mass Index of 30 or greater

• Non-English speaking

• Those patients who will turn 18 during the duration of the study

Related Conditions & MeSH terms

• Dyspepsia
• Eosinophilia

Locations

Country	Name	City	State
United States	Children's Mercy	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (41)

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of a signature of montelukast response using gene expression patterns in biopsy samples from clinical responders and non-responders to montelukast.	Identification of patients who will benefit from montelukast therapy , allowing more efficient, and possibly more effective, care.	Approximately 7-8 weeks
Secondary	Characterization a signature of montelukast response using comparison gene expression patterns in biopsy samples obtained before and after montelukast therapy in children with a positive clinical response to the drug.	Identification and development of a signature of montelukast response applied to eosinophilic gastroenteritis, and more generally to other diseases, such as asthma, where the drug is widely used with variable success.	7-8 weeks.