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BRAVO Study for Functional Dyspepsia (BD)

This study is currently recruiting participants.
Verified April 2017 by Justin Che-Yuen Wu, Chinese University of Hong Kong
Sponsor:
ClinicalTrials.gov Identifier:
NCT01349413
First Posted: May 6, 2011
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Justin Che-Yuen Wu, Chinese University of Hong Kong
  Purpose

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


Condition Intervention Phase
Dyspepsia Gastroesophageal Reflux Drug: Esomeprazole 20mg Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Role of Gastroesophageal Acid Reflux at Squamo-columnar Junction in Functional Dyspepsia

Resource links provided by NLM:


Further study details as provided by Justin Che-Yuen Wu, Chinese University of Hong Kong:

Primary Outcome Measures:
  • The primary outcome measure is the proportion of patients who report positive response to adequate relief of dyspeptic symptoms at week 8. [ Time Frame: Week 8 ]
    The proportion of patients who report positive response


Secondary Outcome Measures:
  • The secondary outcome measures include 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. [ Time Frame: 1st visit and 8 weeks ]
    Dyspeptic symptom scores, symptom association probability of dyspeptic symptoms in relation to esophageal pH


Estimated Enrollment: 130
Study Start Date: August 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Identical looking placebo (once daily)
Other: Placebo
Identical looking placebo
Experimental: Esomeprazole 20mg daily
Esomeprazole 20mg daily Oral for 8 weeks
Drug: Esomeprazole 20mg
Oral Esomeprazole 20mg daily for 8 weeks
Other Name: Nexium

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with functional dyspepsia that fulfill Rome III criteria with inadequate relief of dyspeptic symptoms
  • Age >18
  • Provision of written consent

Exclusion Criteria:

  • Presence of organic pathology identified by upper endoscopy or other investigations
  • Presence of sliding hiatus hernia as defined by flap valve grade IV disruption of morphology at gastro-esophageal junction
  • Concurrent medications that affect gastrointestinal motility
  • Presence of acid reflux or heartburn symptoms of more than twice a month
  • History of gastric surgery
  • H. pylori infection
  • Use of PPI or NSAID in the past 4 weeks
  • Pregnancy
  • Known hypersensitivity to PPI
  Contacts and Locations
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): NCT01349413


Contacts
Contact: Justin CY Wu, MBChB(CUHK) (852)26323476 justinwu@cuhk.edu.hk
Contact: Yawen YC Chan, M Phil (852)26323476 yawenchan@cuhk.edu.hk

Locations
Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Justin CY Wu, MBChB(CUHK)    (852)26323476    justinwu@cuhk.edu.hk   
Principal Investigator: Justin CY Wu, MBChB(CUHK)         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Justin CY Wu, MBChB(CUHK) Chinese University of Hong Kong
  More Information

Additional Information:
Responsible Party: Justin Che-Yuen Wu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01349413     History of Changes
Other Study ID Numbers: BD
First Submitted: May 5, 2011
First Posted: May 6, 2011
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Justin Che-Yuen Wu, Chinese University of Hong Kong:
Functional dyspepsia
symptom response
postprandial fullness
gastroesophageal reflux disease
acid suppression

Additional relevant MeSH terms:
Dyspepsia
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action