The Rabeprazole and Esomeprazole Reflux Assessment Trial

Phase 4

Completed

• Conditions: Gastro-oesophageal reflux disease; Physical Medicine / Rehabilitation - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12607000006448
• Lead Sponsor: Janssen-Cilag Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1908

Inclusion Criteria

1. Able to give written informed consent. 2. 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. To be eligible, subjects 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. 3. Able to understand and complete questionnaires and have access to a telephone. 4. Helicobacter pylori testing is allowed provided that it is not critical to a PPI-prescribing decision and(a) The results of the test must not be divulged to the subject(b) No interventions as a result of the test occur until after the subject’s participation in the study.

Exclusion Criteria

1. Subjects 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. These would include, but are not limited to, alarm symptoms such as unintentional weight loss, progressive difficulty swallowing (dysphagia), iron deficiency anaemia and epigastric mass.2. Significant gastrointestinal disease active in the last 12 months including:i) GI bleedingii) Gastroduodenal ulceriii) Infectious or inflammatory conditions of the intestineiv) Functional dyspepsiav) Malabsorption syndromesvi) Gastrointestinal obstructionvii) Major gastric or oesophageal surgery (excluding appendicectomy or cholecystectomy)viii) Oesophageal stricture or pyloric stenosisix) Extra-oesophageal manifestations of reflux disease3. Barrett's oesophagus (>3cm)4. Zollinger-Ellison Syndrome5. Scleroderma6. Malignancy (other than non-melanoma skin cancers) present within the last 5-years7. Subjects with a known hypersensitivity to rabeprazole or esomeprazole or any PPI8. Female subjects who are currently pregnant or breastfeeding, or who, in the opinion of the investigator, may become pregnant throughout the study9. Use of:i) histamine-2 receptor antagonists (H2RAs) within 7 days of randomisationii) 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.Note – subjects on stable doses of anticholinergics, cholinergics, spasmolytics, opiates and NSAIDs are eligible for entry (where stable dose is defined as one unchanged for > 1 month prior to screening)iii) any drug contra-indicated for use with PPIs10. Any other significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study e.g. past or current history of alcohol or drug abuse, hepatic, renal, pulmonary, respiratory abnormalities etc11. Subjects who are unwilling or unable to abide by the requirements of the study (e.g. completion of daily diary, attendance at study visits)12. Subjects 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to compare in a non-inferiority design, the number of subjects with heartburn and regurgitation symptom resolution after 4 weeks of treatment with either rabeprazole 20mg, esomeprazole 20mg or esomeprazole 40mg. The degree of resolution will be defined as follows:<br>1. Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period<br>2. Satisfactory resolution is a reduction in symptom severity from moderate, severe or very severe to mild, very mild or none at any time within the 4 week period. [Subjects assess symptom response daily with degree of resolution measured at week 4]