MedTrace Logo

BRAVO Study for Functional Dyspepsia

NCT01349413 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2019-01-31

No results posted yet for this study

Summary

Background:

Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of functional dyspepsia is uncertain. Proton pump inhibitor (PPI) has been recommended as the first line treatment for functional dyspepsia. However, the results on effectiveness of PPI are conflicting and it has been suggested that PPI is only effective for acid-related symptoms.

The investigators plan to use a wireless pH monitoring system positioned at the junction of esophagus and stomach to evaluate the chronological relationship between acid exposure at this region and symptoms of dyspepsia as well as its impact on the efficacy of acid suppressive therapy in treatment of functional dyspepsia.

Indication:

Functional dyspepsia patients

Study center(s):

Prince of Wales Hospital, Hong Kong

Aims:

1. To evaluate the chronological relationship between acid exposure at squamo-columnar junction (SCJ) and dyspeptic symptom in different subtypes of functional dyspepsia
2. To evaluate the relationship between acid exposure at squamo-columnar junction and dyspeptic symptom response to PPI
3. To compare the efficacy of PPI and placebo in treating functional dyspepsia patients

Study medication:

Esomeprazole 20mg vs Placebo o.d.

Study design:

Double-blind randomized placebo-controlled trial

Number of subjects: 130

Patient population:

Functional dyspepsia patients without concomitant gastroesophageal reflux disease (GERD)

Duration of study:

1 June 2010 - 30 May 2012

Primary variable(s):

Proportion of patients who report positive response to adequate relief of dyspeptic symptoms at week 8

Secondary variable(s):

Dyspeptic symptom scores, symptom association probability of dyspeptic symptoms in relation to esophageal pH of less than 4 as measured at 1 cm above SCJ.

Number of visits: 2

Hypothesis:

Increased acid exposure at SCJ contributes to dyspeptic symptom and predicts treatment response to PPI in FD patients without concomitant GERD

Conditions

  • Dyspepsia
  • Gastroesophageal Reflux

Interventions

DRUG

Esomeprazole 20mg

Oral Esomeprazole 20mg daily for 8 weeks

OTHER

Placebo

Identical looking placebo

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Justin CY Wu, MBChB(CUHK) · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-24
Primary Completion
2017-12-30
Completion
2018-07-19

Countries

  • Hong Kong

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349413 on ClinicalTrials.gov