Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Esomeprazole or Famotidine in the Management of Aspirin Related Non-ulcer Dyspepsia - a Double Blind Randomized Control Study|
- 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 ] [ Designated as safety issue: No ]
- Treatment success: no significant dyspepsia defined by the Global Dyspepsia Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: esomeprazole
esomeprazole 20 mg
esomeprazole 20 mg po for 4 weeks
Active Comparator: Famotidine
famotidine 40 mg
Famotidine 40 mg po for 4 weeks
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.
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978159
|Contact: FH Ng, M.D.||firstname.lastname@example.org|
|China, Hong Kong|
|Queen Mary Hospital||Recruiting|
|Pokfulam, Hong Kong, China|
|Contact: Ivan Hung 28551111|
|Hong Kong, China|
|Contact: FH Ng, MD 22911743|
|Principal Investigator:||FH Ng, MD||Ruttonjee Hospital|