NCT01349413: BD

BRAVO Study for Functional Dyspepsia

Completed Phase 4 Last updated 31 January 2019

What this trial tests

Phase 4 trial testing Esomeprazole 20mg in Dyspepsia in 130 participants. Completed in 19 July 2018.

Timeline

24 August 2011

Primary endpoint
30 December 2017

19 July 2018

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	diagnostic
Enrollment	130
Start date	24 August 2011
Primary completion	30 December 2017
Estimated completion	19 July 2018
Sites	1 location across Hong Kong

Drugs / interventions tested

• Esomeprazole 20mg — full drug profile →
• Placebo

Conditions studied

• Dyspepsia — all drugs for Dyspepsia →
• Gastroesophageal Reflux — all drugs for Gastroesophageal Reflux →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with Dyspepsia or Gastroesophageal Reflux. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.