NCT00951431

Brief Summary

Functional dyspepsia is one of the most common 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 mechanism of symptom relief is unclear. Most of the previous studies were performed on healthy volunteers who received only a very short course of PPI. The correlation between symptom and gastric emptying is lacking in these studies. Demographic data and anthropometric measurements will be obtained for baseline assessment. Patients are required to complete FGI Screening Questionnaire, Functional dyspepsia symptom questionnaire, gastroesophageal reflux disease (GERD) symptom questionnaire and irritable bowel syndrome (IBS) symptom questionnaire to have a thorough assessment of their GI symptoms. (1) Satiety test and ghrelin profile, and (2)gastric emptying test will be arranged as two individual visits. After baseline investigations, patients will be randomly assigned to either Nexium 20 mg daily or identical looking placebo for 8 weeks. The patients will report their individual dyspeptic symptoms on weekly basis using a self-administered symptom questionnaire. Satiety test and ghrelin profile, gastric emptying study will be repeated at the end of 8-week treatment. Hypothesis: Long-term PPI relieves dyspeptic symptom through acceleration of gastric emptying rate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

December 3, 2009

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2016

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

6.1 years

First QC Date

August 3, 2009

Last Update Submit

January 30, 2019

Conditions

Functional Dyspepsia

Keywords

Functional dyspepsiaPPIpostprandial fullnessdelayed gastric emptying

Outcome Measures

Primary Outcomes (1)

  • gastric emptying rate as measured by BreathID:Area-under-curve (AUC) values at different time points and half-emptying time (t1/2) after 8 weeks of treatment will be used as measures for gastric emptying rate

    8 weeks

Secondary Outcomes (3)

  • calorie intake in satiety test

    8 weeks

  • rate of adequate relief using global symptom assessment

    8 weeks

  • symptom scores

    8 weeks

Study Arms (2)

PPI

EXPERIMENTAL
Drug: Esomeprazole

Control

PLACEBO COMPARATOR
Drug: Placebo

Interventions

EsomeprazoleDRUG

Esomeprazole 20mg daily for 8 weeks

Also known as: Nexium
PPI
PlaceboDRUG

Placebo in the form of study drug

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with functional dyspepsia that fulfill Rome III criteria attending GI clinic or endoscopy center
  • Age 18-60 years old
  • Provision of written consent
  • Negative upper endoscopy (oesophagogastroduodenoscopy or OGD) finding

You may not qualify if:

  • Diabetes mellitis
  • Frequent (once or more per week) acid reflux or heartburn symptoms
  • Concurrent medications that affect GI motility
  • Concurrent use of TCA
  • History of gastric surgery
  • Organic disease as cause of dyspepsia
  • H. pylori infection
  • Use of PPI or NSAID in the past 4 weeks
  • Pregnancy
  • Known hypersensitivity to PPI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Justin C.Y. Wu, MBChB(CUHK)

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

December 3, 2009

Primary Completion

December 31, 2015

Study Completion

February 19, 2016

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

HK(1)