Back to resultsOpen-Label Placebo for Functional Dyspepsia
Primary Purpose
Dyspepsia
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia
Eligibility Criteria
Inclusion Criteria:
- Functional Dyspepsia
Exclusion Criteria:
-
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
open-label placebo
treatment as usual
Arm Description
open-label placebo
Outcomes
Primary Outcome Measures
dyspepsia severity on a VAS from 0-100
How severe have your dyspepsia symptoms been over the past 7 days (on a VAS from 0-100)?
Secondary Outcome Measures
Full Information
NCT ID
NCT03745781
First Posted
November 14, 2018
Last Updated
May 4, 2020
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03745781
Brief Title
Open-Label Placebo for Functional Dyspepsia
Official Title
Open-Label Placebo for Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
October 7, 2019 (Actual)
Study Completion Date
October 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is evaluating the efficacy of open-label placebo for the treatment of functional dyspepsia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: open-label placebo Arm 2: treatment as usual control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open-label placebo
Arm Type
Experimental
Arm Description
open-label placebo
Arm Title
treatment as usual
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
placebo pills
Primary Outcome Measure Information:
Title
dyspepsia severity on a VAS from 0-100
Description
How severe have your dyspepsia symptoms been over the past 7 days (on a VAS from 0-100)?
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Functional Dyspepsia
Exclusion Criteria:
-
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open-Label Placebo for Functional Dyspepsia
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