Aspirin | Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia
Aspirin research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - 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 Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:esomeprazoleesomeprazole 20 mg po for 4 weeks
Drug:FamotidineFamotidine 40 mg po for 4 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
esomeprazoleesomeprazole 20 mg
Famotidinefamotidine 40 mg
Start Date: September 2009
Completed Date: December 2013
Phase: Phase 4
Primary Outcome: 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
Secondary Outcome: Treatment success: no significant dyspepsia defined by the Global Dyspepsia Score
Study sponsors, principal investigator, and references
Principal Investigator: FH Ng, MD
Lead Sponsor: Ruttonjee Hospital
Collaborator: Queen Mary Hospital, Hong Kong