BRAVO Study for Functional Dyspepsia

NCT01349413 | Completed Phase 4

• 1 other identifier: BD
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

Dyspepsia; Gastroesophageal Reflux

Keywords

Functional dyspepsia; symptom response; postprandial fullness; gastroesophageal reflux disease; acid suppression

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the proportion of patients who report positive response to adequate relief of dyspeptic symptoms at week 8.

  The proportion of patients who report positive response

  Week 8

Secondary Outcomes (1)

• 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.

  1st visit and 8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Identical looking placebo (once daily)

Other: Placebo

Esomeprazole 20mg daily

EXPERIMENTAL

Esomeprazole 20mg daily Oral for 8 weeks

Drug: Esomeprazole 20mg

Interventions

Esomeprazole 20mg DRUG

Oral Esomeprazole 20mg daily for 8 weeks

Also known as: Nexium

Esomeprazole 20mg daily

Placebo OTHER

Identical looking placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Links

• The Chinese University of Hong Kong

MeSH Terms

Conditions

Dyspepsia; Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Justin CY Wu, MBChB(CUHK)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 6, 2011
• Study Start: August 24, 2011
• Primary Completion: December 30, 2017
• Study Completion: July 19, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)