Gastric Functions & Proton Pump Inhibitor(PPI) Study - Full Text View

Sponsor:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00951431

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
Functional Dyspepsia	Drug: Esomeprazole Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control 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

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

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:	June 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PPI: Experimental	Drug: Esomeprazole Esomeprazole 20mg daily for 8 weeks
Control: Placebo Comparator	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
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:	The Chinese Unviersity of Hong Kong ( Prof Justin C.Y. Wu )
Study ID Numbers:	GFP
Study First Received:	August 3, 2009
Last Updated:	January 12, 2010
ClinicalTrials.gov Identifier:	NCT00951431 History of Changes
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:

Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Dyspepsia
Pharmacologic Actions

Signs and Symptoms
Digestive System Diseases
Stomach Diseases
Proton Pump Inhibitors
Therapeutic Uses
Anti-Ulcer Agents
Gastroenteritis
Gastritis

ClinicalTrials.gov processed this record on March 18, 2010