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Gastric Functions & Proton Pump Inhibitor( PPI) Study

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ClinicalTrials.gov Identifier: NCT00951431
Recruitment Status : Unknown
Verified February 2011 by Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : August 4, 2009
Last Update Posted : February 21, 2011
Sponsor:
Information provided by:

Study Description
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
Nonulcer Dyspepsia Drug: Esomeprazole Drug: Placebo Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Study Start Date : December 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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
Contacts and Locations

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


Contacts
Contact: Justin C.Y. Wu, MBChB(CUHK) (852) 2632-3593 justinwu@cuhk.edu.hk
Contact: Yawen Chan, MPhil (852) 2632-3476 yawenchan@cuhk.edu.hk

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

Additional Information:
Responsible Party: Prof Justin C.Y. Wu, The Chinese Unviersity 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 21, 2011
Last Verified: February 2011

Keywords provided by Chinese University of Hong Kong:
Functional dyspepsia
PPI
postprandial fullness
delayed gastric emptying

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