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Gastric Functions & Proton Pump Inhibitor( PPI) Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00951431
First received: August 3, 2009
Last updated: February 18, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Nonulcer Dyspepsia
 Drug: Esomeprazole
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Proton Pump Inhibitor on Gastric Emptying and Satiety Function in Patients With Functional Dyspepsia

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • calorie intake in satiety test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • rate of adequate relief using global symptom assessment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • symptom scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Institute of Digestive Disease  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: August 3, 2009
Last Updated: February 18, 2011
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
PPI
postprandial fullness
delayed gastric emptying

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

ClinicalTrials.gov processed this record on May 16, 2013