Esomeprazole or Famotidine in the Management of Aspirin Related Non-ulcer Dyspepsia - a Double Blind Randomized Control Study
18 Years
N/A
Both
Aspirin, Dyspepsia
Trial Information
Esomeprazole or Famotidine in the Management of Aspirin Related Non-ulcer Dyspepsia - a Double Blind Randomized Control Study
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
4 weeks
Safety Issue:
No
Principal Investigator
FH Ng, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ruttonjee Hospital
Authority:
Hong Kong: Hospital Authority
Study ID:
HKEC 2009-058
NCT ID:
NCT00978159
Start Date:
September 2009
Completion Date:
December 2013
Related Keywords:
- Aspirin
- Dyspepsia
- esomeprazole
- famotidine
- aspirin
- dyspepsia
- Dyspepsia
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