Status:
UNKNOWN
Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia
Lead Sponsor:
Ruttonjee Hospital
Collaborating Sponsors:
Queen Mary Hospital, Hong Kong
Conditions:
Aspirin
Dyspepsia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 p...
Detailed Description
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 dyspep...
Eligibility Criteria
Inclusion
- at least moderate pain or discomfort (or both) centered in the upper abdomen as their predominant symptoms for 7 days before randomization; taking low dose aspirin (80-300 mg daily),and insignificant upper endoscopic finding. At least moderate pain or discomfort is defined if the HKDI was more than or equal to 16.
- H. Pylori: In patients with have successful eradication of H. pylori and had dyspepsia with HKDI \>=16 at the 6th week after eradication therapy can be recruited.In patients without H. pylori infection, they can be recruited immediately.
Exclusion
- non-Chinese speaking
- significant endoscopic finding
- typical biliary colic
- predominant heartburn or symptoms of the irritable bowel syndrome
- a history of peptic ulcer or gastroesophageal reflux
- unintentional weight loss previous gastric or duodenal surgery
- thrombocytopenia
- renal failure with estimated creatinine clearance less than 10 ml/min
- active cancer
- known allergic to aspirin, famotidine or esomeprazole
- pregnancy, lactation, child-bearing potential in the absence of contraception
- planned co-prescription of nonsteroidal anti-inflammatory drugs
- corticosteroid, clopidogrel or anticoagulant
- anxiety neurosis, depression, psychosomatic disorder
- investigation for dyspepsia with endoscopy or barium series before aspirin therapy or disorders that might modify the absorption of study drugs
- ongoing treatment with a histamine H2-receptor antagonist, a prostaglandin, or a prokinetic drug during the 7 days before enrollment was not permitted, nor was treatment with a proton-pump inhibitor, or bismuth in the 30 days before enrollment
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00978159
Start Date
September 1 2009
End Date
December 1 2013
Last Update
June 6 2012
Active Locations (2)
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1
Queen Mary Hospital
Pokfulam, Hong Kong, China
2
Ruttonjee Hospital
Hong Kong, China