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Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01808196
Recruitment Status : Completed
First Posted : March 11, 2013
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Eosinophilic Esophagitis
Connective Tissue Disorders
Intervention Drug: Losartan Potassium
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Losartan
Hide Arm/Group Description

Participants with eosinophilic esophagitis receive the Losartan daily

Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.

Period Title: Overall Study
Started 6
Completed 5
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Losartan
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Participants with eosinophilic esophagitis receive the Losartan daily

Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
13.4  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
1
  16.7%
Male
5
  83.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Peak Eosinophil Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Eosinophils per high power field
Distal Peak Eosinophil Counts Number Analyzed 5 participants
108  (86)
Proximal Peak Eosinophil Counts Number Analyzed 6 participants
40  (37)
[1]
Measure Analysis Population Description: One subjects biopsies were not evaluated by research pathologist
Pediatric EoE Symptom Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 5 participants
28  (20)
[1]
Measure Description: Pediatric EoE Symptom score measures the frequency and severity of symptoms including nausea/vomiting, dysphagia, pain, and reflux. Scores range from 0 to 100. Higher scores indicate more frequent and/or severe symptoms.
[2]
Measure Analysis Population Description: Questionnaire not answered by one subject
1.Primary Outcome
Title Percent of Participants in Histologic Remission at 16 Weeks
Hide Description Percent of participants with peak eosinophil count < 15 eosinophils/high power field (remission) in distal and proximal esophagus
Time Frame 16 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan
Hide Arm/Group Description:

Participants with eosinophilic esophagitis receive Losartan daily

Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of participants
Distal Remission 17
Proximal Remission 17
2.Secondary Outcome
Title Change in Peak Eosinophil Count at 16 Weeks
Hide Description Mean change in peak eosinophil count from baseline
Time Frame Baseline, 16 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan
Hide Arm/Group Description:

Participants with eosinophilic esophagitis receive Losartan daily

Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: eosinophils/high power field
Change in Distal Peak Count -43  (107)
Change in Proximal Peak Count 3  (62)
3.Secondary Outcome
Title Change in Pediatric EoE Symptom Score at 16 Weeks
Hide Description The PEESS V2.0 questionnaire captures EoE-specific symptoms (dysphagia, GERD, nausea/vomiting, and pain) as reported by parents. The range for PEESS v2.0 scores is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. Scores were obtained at baseline and 16 weeks. Change in score is defined as total score at 16 weeks minus total score at baseline.
Time Frame Baseline, 16 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Losartan
Hide Arm/Group Description:

Participants with eosinophilic esophagitis receive Losartan daily

Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-11  (12)
Time Frame From consent to cessation of study which is approximately 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Losartan
Hide Arm/Group Description

Participants with eosinophilic esophagitis receive Losartan daily

Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.

All-Cause Mortality
Losartan
Affected / at Risk (%)
Total   0/6 (0.00%)    
Hide Serious Adverse Events
Losartan
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Losartan
Affected / at Risk (%) # Events
Total   2/6 (33.33%)    
Ear and labyrinth disorders   
Hearing loss *  1/6 (16.67%) 
Gastrointestinal disorders   
Abdominal Pain *  1/6 (16.67%)  2
Food impaction *  1/6 (16.67%) 
Heartburn *  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders   
Back Pain *  1/6 (16.67%) 
Nervous system disorders   
Headache *  1/6 (16.67%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pablo Abonia, MD
Organization: Cincinnati Children's Hospital Medical Center
Phone: 513-636-
EMail: pablo.abonia@cchmc.org
Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01808196    
Other Study ID Numbers: 2012-0106
First Submitted: January 30, 2013
First Posted: March 11, 2013
Results First Submitted: August 31, 2020
Results First Posted: September 24, 2020
Last Update Posted: September 24, 2020