Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00978159
Other study ID # HKEC 2009-058
Secondary ID
Status Recruiting
Phase Phase 4
First received September 15, 2009
Last updated June 5, 2012
Start date September 2009
Est. completion date December 2013

Study information

Verified date June 2012
Source Ruttonjee Hospital
Contact FH Ng, M.D.
Phone 22911743
Email ngfhong@hkucc.hku.hk
Is FDA regulated No
Health authority Hong Kong: Hospital Authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 128
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
esomeprazole
esomeprazole 20 mg po for 4 weeks
Famotidine
Famotidine 40 mg po for 4 weeks

Locations

Country Name City State
China Ruttonjee Hospital Hong Kong
China Queen Mary Hospital Pokfulam Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
Ruttonjee Hospital Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Treatment success: no significant dyspepsia defined by the Global Dyspepsia Score 4 weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT06094062 - Smartphone App-assisted PPI N/A
Completed NCT03941288 - Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia Phase 2
Completed NCT04429802 - The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Withdrawn NCT02863822 - Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia. N/A
Completed NCT00723502 - Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients Phase 2
Completed NCT00217347 - Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy N/A
Terminated NCT00220844 - Tricyclic Antidepressants (TCAs) on Gastric Emptying N/A
Completed NCT00148603 - Montelukast in the Treatment of Duodenal Eosinophilia N/A
Completed NCT00232037 - Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia Phase 3
Completed NCT00232102 - Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia Phase 3
Completed NCT00164996 - Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia Phase 3
Completed NCT00110968 - Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia Phase 3
Recruiting NCT05718960 - Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia N/A
Terminated NCT04247100 - A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders N/A
Completed NCT05750641 - The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study
Completed NCT04697641 - Helicobacter Pylori Eradication in Functional Dyspepsia N/A
Completed NCT03252743 - ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study. N/A
Recruiting NCT04918329 - Functional Digestive Disorders Observatory
Recruiting NCT01696734 - Domperidone in Treating Patients With Gastrointestinal Disorders Phase 3