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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,392
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
Unnamed facility
Belconnen, Australia
Unnamed facility
Bondi Junction, Australia
Unnamed facility
The Number of Patients With Complete Resolution of Heartburn by Week 4
Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.
Time frame: week 4 of treatment
The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4
Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.
Time frame: 4 weeks
The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4
Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild) assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.
Time frame: 4 weeks
The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4
Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild)assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.
Time frame: 4 weeks
The Median Time to Complete Resolution of Heartburn Symptoms.
Time frame: week 4 of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Brookvale, Australia
Unnamed facility
Browns Plains, Australia
Unnamed facility
Campbelltown, Australia
Unnamed facility
Campsie, Australia
Unnamed facility
Caringbah, Australia
Unnamed facility
Castle Hill, Australia
Unnamed facility
Charlestown, Australia
Unnamed facility
Dapto, Australia
...and 15 more locations
The Median Time to Complete Relief of Regurgitation Symptoms
Time frame: 4 weeks
The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods
Time frame: 4 weeks