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
:
Active, not recruiting
First Posted
: March 11, 2013
Last Update Posted
: January 29, 2018
|
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | January 30, 2013 | ||||||
First Posted Date ICMJE | March 11, 2013 | ||||||
Last Update Posted Date | January 29, 2018 | ||||||
Study Start Date ICMJE | April 2013 | ||||||
Estimated Primary Completion Date | August 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
||||||
Original Primary Outcome Measures ICMJE |
Number of participants with reduction of esophageal eosinophils [ Time Frame: up to five years ] Tissue samples will be obtained from the esophagus from participants to determine the effects of losartan compared to placebo on the reduction of esophageal eosinophils in participants with eosinophilic esophagitis with or without a connective tissue disorder. It is planned to evaluate the reduction as follows:
|
||||||
Change History | Complete list of historical versions of study NCT01808196 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE |
|
||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD | ||||||
Official Title ICMJE | A Preliminary, Open-label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder. | ||||||
Brief Summary | The purpose of this research study is to test the safety of losartan potassium and see what effects (good and bad) it has on you and your eosinophilic esophagitis. | ||||||
Detailed Description | Losartan is a drug that is approved by the United States Food and Drug Administration (FDA) for use in adults and children over 6 years of age who have high blood pressure. Losartan has been safe when administered to patients with normal blood pressure. This medication has not been studied in people with eosinophilic esophagitis or connective tissue disorder. Eosinophils are a type of white blood cell that induces inflammation. Eosinophils with other inflammatory cells produce a protein called TGF-β, which may contribute to part of EoE. Losartan may reduce the amount of this protein and therefore, be a treatment for eosinophilic esophagitis. You will be in the research study for approximately 4 months. Participation in this research study will involve 9 study visits. Of the 9 study visits, at least 3 visits will take place in the clinic; the other visits may take place over the telephone. Throughout the study, the following activities will occur:
This is an open-label trial, which means that if you choose to enroll and you meet screening criteria, you will receive Losartan as a treatment. You will start the study drug at a low dose. It will be increased at vist 3 the 1 month visit. The dose of study drug will be increased depending on your weight and how well you tolerate each dose but will not exceed 100mg of study drug per day. It may be increased or decreased during the study if there are any side effects. If you do not have certain side effects, you will take each dose of the study drug between 21 and 28 days until your next study visit. You will swallow a pill or liquid once or twice a day. This study will consist of 4 phases: screening, treatment (titration and maintenance), end of treatment, and follow-up. Participants that are between 5 to 18 years of age, as well as the parent or legal guardian will be asked to complete questionnaires of quality-of-life symptom severity questionnaires. Participants between the age of 19 and 21 will also have to fill out these questionnaires, but parents/guardians will not have to fill these out. If you are the parent or caretaker, the only study activity in which you will be involved is the completion of questionnaires about you and your family. |
||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
Condition ICMJE |
|
||||||
Intervention ICMJE | Drug: Losartan Potassium
The medication dosage for Losartan will change throughout this study slowly increasing to a larger amount. You will start the study drug at a low dose. It will be increased at Visit 3/Week 4, unless you have certain side effects. The dose of study drug will be increased depending on your weight and how well you tolerate each dose and will not exceed 100mg of study drug. It may be increased or decreased during the study if there are any side effects.
Other Name: Angiotensin II Receptor Antagonists |
||||||
Study Arms |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
6 | ||||||
Original Estimated Enrollment ICMJE |
44 | ||||||
Estimated Study Completion Date | August 2018 | ||||||
Estimated Primary Completion Date | August 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender |
|
||||||
Ages | 5 Years to 21 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01808196 | ||||||
Other Study ID Numbers ICMJE | 2012-0106 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Children's Hospital Medical Center, Cincinnati | ||||||
Study Sponsor ICMJE | Children's Hospital Medical Center, Cincinnati | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Children's Hospital Medical Center, Cincinnati | ||||||
Verification Date | January 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |