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

NCT00978159 | Unknown Phase 4 DMC

• 1 other identifier: HKEC 2009-058
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Aspirin; Dyspepsia

Keywords

esomeprazole; famotidine; aspirin; dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treatment success: no significant dyspepsia defined by the Global Dyspepsia Score

  4 weeks

Study Arms (2)

esomeprazole

ACTIVE COMPARATOR

esomeprazole 20 mg

Drug: esomeprazole

Famotidine

ACTIVE COMPARATOR

famotidine 40 mg

Drug: Famotidine

Interventions

esomeprazole DRUG

esomeprazole 20 mg po for 4 weeks

esomeprazole

Famotidine DRUG

Famotidine 40 mg po for 4 weeks

Famotidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruttonjee Hospital: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (2)

Queen Mary Hospital

Pokfulam, Hong Kong, China

RECRUITING

Ruttonjee Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Dyspepsia

Interventions

Esomeprazole; Famotidine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles

Study Officials

• FH Ng, MD

  Ruttonjee Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

FH Ng, M.D.

CONTACT

22911743; ngfhong@hkucc.hku.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CON

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

CN (2)