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Trial record 5 of 41 for:    Recruiting, Not yet recruiting, Available Studies | Dyspepsia

Open-Label Placebo for Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT03745781
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Judy Nee, Beth Israel Deaconess Medical Center

Brief Summary:
The study is evaluating the efficacy of open-label placebo for the treatment of functional dyspepsia.

Condition or disease Intervention/treatment Phase
Dyspepsia Drug: Placebos Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arm 1: open-label placebo Arm 2: treatment as usual control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Placebo for Functional Dyspepsia
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: open-label placebo
open-label placebo
Drug: Placebos
placebo pills

No Intervention: treatment as usual



Primary Outcome Measures :
  1. dyspepsia severity on a VAS from 0-100 [ Time Frame: 3 weeks ]
    How severe have your dyspepsia symptoms been over the past 7 days (on a VAS from 0-100)?



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Functional Dyspepsia

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745781


Contacts
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Contact: Vivian Cheng 6176670682 vcheng2@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Vivian Cheng, MS, MPH    617-667-0682    vcheng2@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center

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Responsible Party: Judy Nee, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03745781     History of Changes
Other Study ID Numbers: 2018P000294
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms