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
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||155 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Esomeprazole 20mg daily for 8 weeks
Other Name: Nexium
|Placebo Comparator: Control||
Placebo in the form of study drug
- 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 ]
- calorie intake in satiety test [ Time Frame: 8 weeks ]
- rate of adequate relief using global symptom assessment [ Time Frame: 8 weeks ]
- symptom scores [ Time Frame: 8 weeks ]
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
|Prince of Wales Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Justin C.Y. Wu, MBChB(CUHK)||Chinese University of Hong Kong|