A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg
Condition: Gastro-oesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Esomeprazole; Rabeprazole; Esomeprazole
Intervention description: 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily; 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily; 40mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Intervention MeSH terms: Esomeprazole; Rabeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1392.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal Reflux; Heartburn; Proton pump inhibitor; GORD

Summary:

      The primary objective of this study is to compare, the number of patients with heartburn and
      regurgitation symptom resolution after treatment with either rabeprazole 20 mg, esomeprazole
      20 mg or esomeprazole 40 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heartburn (defined as a feeling of burning or pain, rising from the epigastrium or
             lower part of the chest up towards the neck) with or without regurgitation

          -  Patients must have had episodes of heartburn with or without regurgitation for 3
             months or longer, and for >= 3 days in the 7 days prior to randomisation

          -  Able to understand and complete questionnaires, able to give written informed consent,
             and have access to a telephone

        Exclusion Criteria:

          -  Patients requiring endoscopy within 4 weeks of randomisation or with gastrointestinal
             symptoms that, in the opinion of the investigator, require further investigation prior
             to or coincident with initiation of PPI therapy which would include, but are not
             limited to, alarm symptoms such as unintentional weight loss, progressive difficulty
             swallowing (dysphagia), iron deficiency anaemia and epigastric mass

          -  Significant gastrointestinal obstruction, major gastric or oesophageal surgery
             (excluding appendectomy or cholecystectomy), oesophageal stricture or pyloric
             stenosis, extra-oesophageal manifestations of reflux disease

          -  Patients with Barrett's oesophagus (>3cm), Zollinger-Ellison Syndrome, scleroderma,
             malignancy (other than non-melanoma skin cancers) present within the last 5 years,
             hypersensitivity to rabeprazole or esomeprazole or any PPI, or any other significant
             condition that, in the opinion of the investigator, could interfere with the patients
             participation or compliance in the study such as past or current history of alcohol or
             drug abuse, hepatic, renal, pulmonary, respiratory abnormalities, or who have
             participated in an investigational drug or investigational device study within 30 days
             prior to the baseline visit or who are expected to do so during the 4 week study
             period

          -  Female patients who are currently pregnant or breast feeding, or who, in the opinion
             of the investigator, may become pregnant throughout the study

          -  Use of histamine-2 receptor antagonists (H2RAs) within 7 days of randomisation,
             anticholinergics, cholinergics, spasmolytics, opiates, sucralfate, proton pump
             inhibitors (PPIs), prokinetics, antibiotics (in relation to H. pylori treatment) or
             bismuth compounds within 14 days of randomisation