A Phase 4 interventional study of esomeprazole and Famotidine in Aspirin and Dyspepsia, sponsored by Ruttonjee Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-06.
Sponsored by Ruttonjee Hospital · Phase 4, Interventional, and Treatment
Aspirin can prevent ischemic vascular disease but is commonly complicated by dyspepsia in 30% of patients. Patients, who have aspirin related dyspepsia, commonly underwent upper endoscopy to exclude peptic ulcer disease or gastric cancers. For those without significant lesions in the stomach and duodenum (non-ulcer dyspepsia), the best approach in the management is unclear. The objective of this study is to compare the efficacy of esomeprazole and famotidine in the control of dyspeptic symptom. After giving consent, patients will be randomised to receive either esomeprazole 20 mg daily or famotidine 40 mg daily in a double blinded manner. The patient will be followed-up at the 2nd and 4th week. The study will be completed at the 4th week. The primary analysis will be the efficacy in the control of dyspepsia symptom between the two groups.
The objective of this double blinded randomized controlled study is to compare the efficacy of esomeprazole with famotidine in the control of dyspepsia in patients with aspirin related nonulcer dyspepsia NUD.
Method
The study shall be applied for approval from the Ethic Committee of Hong Kong West and East Cluster and shall be registered to the Clinical Trial Governance before the recruitment of the first patient.
Measuring instruments \& Definitions
Hong Kong Dyspepsia Index (HKDI)
The presence or absence of dyspepsia was measured by the validated Hong Kong index of dyspepsia . This questionnaire could be used in epidemiological studies assessing the frequency and severity of dyspepsia in patient populations and also in interventional studies in functional dyspepsia.This index consisted of 12 questions on the severity of gastrointestinal symptoms, graded according to a five-point Likert scale (1- 5, from asymptomatic to very severe symptoms). A cut-off score of equal to or greater than 16 was determined to discriminate between controls and dyspeptic patients.
Global Dyspepsia Score
The global severity of dyspepsia will be measured by the Global Dyspepsia Score, which was a four-point scale in which a score of 0 indicated no pain or discomfort, a score of 1 mild pain or discomfort, a score of 2 moderate (annoying but not interfering with the daily routine) pain or discomfort, and a score of 3 severe (markedly interfering with the daily routine) pain or discomfort over the last 7 days . This scale is reliable, valid, and responsive and provides global assessment of symptoms in the western population . Significant dyspepsia was defined when Global Dyspepsia Score was more than or equal to 2 moderate.
Definition of significant endoscopic finding
Significant finding was defined as the presence of reflux esophagitis, Barrett's esophagus, gastric or duodenal ulceration, duodenal or esophageal erosions, or cancer and those with more than five gastric erosions on upper endoscopy. (Tally N, NEJM 1999)
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's planned enrollment of 128 is above the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Ruttonjee Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
esomeprazole 20 mg
Drug: esomeprazole
famotidine 40 mg
Drug: Famotidine
esomeprazole 20 mg po for 4 weeks
Famotidine 40 mg po for 4 weeks
Treatment success : The HKDI is less than 16. Treatment was considered to have failed if a patient had taken medication for dyspepsia (other than antacids) during the study period
Time frame: 4 weeks
Treatment success: no significant dyspepsia defined by the Global Dyspepsia Score
Time frame: 4 weeks
This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Ruttonjee Hospital