Dyspepsia | BRAVO Study for Functional Dyspepsia
Dyspepsia research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Esomeprazole 20mgOral Esomeprazole 20mg daily for 8 weeks
Other:PlaceboIdentical looking placebo
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PlaceboIdentical looking placebo (once daily)
Esomeprazole 20mg dailyEsomeprazole 20mg daily Oral for 8 weeks
Start Date: August 2011
Completed Date: December 2017
Phase: Phase 4
Primary Outcome: The primary outcome measure is the proportion of patients who report positive response to adequate relief of dyspeptic symptoms at week 8.
Secondary Outcome: 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.
Study sponsors, principal investigator, and references
Principal Investigator: Justin CY Wu, MBChB(CUHK)
Lead Sponsor: Chinese University of Hong Kong