BRAVO Study for Functional Dyspepsia (BD)
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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:
- To evaluate the chronological relationship between acid exposure at squamo-columnar junction (SCJ) and dyspeptic symptom in different subtypes of functional dyspepsia
- To evaluate the relationship between acid exposure at squamo-columnar junction and dyspeptic symptom response to PPI
- 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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Role of Gastroesophageal Acid Reflux at Squamo-columnar Junction in Functional Dyspepsia |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 130 |
| Study Start Date: | August 2011 |
| Estimated Primary Completion Date: | December 2013 (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: PPI
Esomeprazole 20mg daily
|
Drug: Esomeprazole 20mg
Oral Esomeprazole 20mg daily for 8 weeks
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Justin C.Y. Wu, MBChB(CUHK) | (852)26323476 | justinwu@cuhk.edu.hk |
| Contact: Yawen Chan, M Phil | (852)26323476 | yawenchan@cuhk.edu.hk |
| Hong Kong | |
| Prince of Wales Hospital | Recruiting |
| Hong Kong, Hong Kong | |
| Contact: Justin C.Y. Wu, MBChB(CUHK) (852)26323476 justinwu@cuhk.edu.hk | |
| Principal Investigator: Justin C.Y. Wu, MBChB(CUHK) | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Justin Che-Yuen Wu, Professor, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01349413 History of Changes |
| Other Study ID Numbers: | BD |
| Study First Received: | May 5, 2011 |
| Last Updated: | February 17, 2013 |
| Health Authority: | Hong Kong: Department of Health Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by Chinese University of Hong Kong:
|
Functional dyspepsia symptom response postprandial fullness gastroesophageal reflux disease acid suppression |
Additional relevant MeSH terms:
|
Dyspepsia Gastroesophageal Reflux Signs and Symptoms, Digestive Signs and Symptoms Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Omeprazole Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013