Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia

Esomeprazole or Famotidine in the Management of Aspirin Related Non-ulcer Dyspepsia - a Double Blind Randomized Control 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.

Study Overview

• Status: Unknown
• Conditions: Dyspepsia; Aspirin
• Intervention / Treatment: Drug: esomeprazole; Drug: Famotidine

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 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)

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • Ruttonjee Hospital
    • Contact: FH Ng, MD; Phone Number: 22911743
  • Hong Kong
    • Pokfulam, Hong Kong, China
      • Recruiting
      • Queen Mary Hospital
      • Contact: Ivan Hung; Phone Number: 28551111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: esomeprazole; esomeprazole 20 mg	Drug: esomeprazole; esomeprazole 20 mg po for 4 weeks
Active Comparator: Famotidine; famotidine 40 mg	Drug: Famotidine; Famotidine 40 mg po for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment success: no significant dyspepsia defined by the Global Dyspepsia Score	4 weeks

Collaborators and Investigators

• Sponsor: Ruttonjee Hospital
• Collaborators: Queen Mary Hospital, Hong Kong
• Investigators: Principal Investigator: FH Ng, MD, Ruttonjee Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: September 15, 2009
• First Submitted That Met QC Criteria: September 15, 2009
• First Posted (Estimate): September 16, 2009

Study Record Updates

• Last Update Posted (Estimate): June 6, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: aspirin; esomeprazole; dyspepsia; famotidine
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Famotidine; Esomeprazole
• Other Study ID Numbers: HKEC 2009-058