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Gastric Functions & Proton Pump Inhibitor( PPI) Study

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ClinicalTrials.gov Identifier: NCT00951431
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Justin Che-Yuen Wu, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Esomeprazole Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Proton Pump Inhibitor on Gastric Emptying and Satiety Function in Patients With Functional Dyspepsia
Actual Study Start Date : December 3, 2009
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : February 19, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: PPI Drug: Esomeprazole
Esomeprazole 20mg daily for 8 weeks
Other Name: Nexium

Placebo Comparator: Control Drug: Placebo
Placebo in the form of study drug




Primary Outcome Measures :
  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 [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. calorie intake in satiety test [ Time Frame: 8 weeks ]
  2. rate of adequate relief using global symptom assessment [ Time Frame: 8 weeks ]
  3. symptom scores [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT00951431


Locations
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Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Justin C.Y. Wu, MBChB(CUHK) Chinese University of Hong Kong

Additional Information:
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Responsible Party: Justin Che-Yuen Wu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00951431     History of Changes
Other Study ID Numbers: GFP
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

Keywords provided by Justin Che-Yuen Wu, Chinese University of Hong Kong:
Functional dyspepsia
PPI
postprandial fullness
delayed gastric emptying

Additional relevant MeSH terms:
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Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action