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

NCT ID: NCT00464308

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-05-31

Brief 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.

Detailed Description

The study is designed to be conducted in a realistic General Practice (GP) setting, enrolling typical Gastro-oesophageal Reflux Disease (GORD) patients that present for treatment, and for whom a Proton Pump Inhibitor (PPI) would normally be prescribed. The study will be conducted over a 4-week period on the basis that current GP standard practice is to treat the GORD patient for a period of 4-weeks prior to reassessment and further follow-up if required. This study is conducted in patients with GORD - associated heartburn (with or without regurgitation) at multiple GP centers, treatment is assigned based on chance (randomized), similar to the toss of a coin and neither doctor or patient knows which treatment they will receive (double-blinded). Following screening to determine eligibility, patients will be randomized to receive oral treatment with either, 20 mg rabeprazole, 20 mg esomeprazole or 40 mg esomeprazole once daily for 4 weeks. This 4-week study encompasses 2 protocol-mandated visits (baseline on day 0 and final visit on day 28). It is hypothesized that rabeprazole 20 mg will be no less effective than (non-inferior) esomeprazole 40 mg for the degree of GORD symptom resolution. Patients will take one tablet (rabeprazole 20 mg or placebo) and one capsule (esomeprazole 20 mg, esomeprazole 40 mg or placebo) each day for 28 days. The study medication will be taken once daily in the morning before breakfast, except the first dose, which will be taken during Visit 1.

Conditions

Gastro-oesophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

001

Esomeprazole 40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Group Type: ACTIVE_COMPARATOR

Esomeprazole

Intervention Type: DRUG

40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

002

Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Group Type: ACTIVE_COMPARATOR

Esomeprazole

Intervention Type: DRUG

20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

003

Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Group Type: ACTIVE_COMPARATOR

Rabeprazole

Intervention Type: DRUG

20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Interventions

Esomeprazole

20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Intervention Type: DRUG

Rabeprazole

20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Intervention Type: DRUG

Esomeprazole

40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag Pty Ltd Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Pty Ltd

Locations

Belconnen, , Australia

Bondi Junction, , Australia

Brookvale, , Australia

Browns Plains, , Australia

Campbelltown, , Australia

Campsie, , Australia

Caringbah, , Australia

Castle Hill, , Australia

Charlestown, , Australia

Dapto, , Australia

Darlinghurst, , Australia

Dubbo, , Australia

Elizabeth, , Australia

Fairfield, , Australia

Hoppers Crossing, , Australia

Ingleburn, , Australia

Leichhardt, , Australia

Maroubra, , Australia

Melton, , Australia

Mount Druitt, , Australia

Oaklands Park, , Australia

Royal Park, , Australia

Sydney, , Australia

Wentworthville, , Australia

Wyoming, , Australia

Countries

Australia

References

Biscola FT, Abe CM, Guth BE. Determination of adhesin gene sequences in, and biofilm formation by, O157 and non-O157 Shiga toxin-producing Escherichia coli strains isolated from different sources. Appl Environ Microbiol. 2011 Apr;77(7):2201-8. doi: 10.1128/AEM.01920-10. Epub 2011 Feb 11.

Reference Type: DERIVED

PMID: 21317257 (View on PubMed)

Eggleston A, Katelaris PH, Nandurkar S, Thorpe P, Holtmann G; Treat Study Group. Clinical trial: the treatment of gastro-oesophageal reflux disease in primary care--prospective randomized comparison of rabeprazole 20 mg with esomeprazole 20 and 40 mg. Aliment Pharmacol Ther. 2009 May 1;29(9):967-78. doi: 10.1111/j.1365-2036.2009.03948.x. Epub 2009 Feb 3.

Reference Type: DERIVED

PMID: 19210493 (View on PubMed)

Other Identifiers

CR006397

Identifier Type: -

Identifier Source: org_study_id