NCT03745781

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Dec 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2019

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

November 14, 2018

Last Update Submit

May 4, 2020

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • 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)?

    3 weeks

Study Arms (2)

open-label placebo

EXPERIMENTAL

open-label placebo

Drug: Placebos

treatment as usual

NO INTERVENTION

Interventions

PlacebosDRUG

placebo pills

open-label placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Functional Dyspepsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Arm 1: open-label placebo Arm 2: treatment as usual control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 19, 2018

Study Start

December 1, 2018

Primary Completion

October 7, 2019

Study Completion

October 7, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)