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
Information source: Janssen-Cilag Pty Ltd
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastro-oesophageal Reflux
Intervention: Esomeprazole (Drug); Rabeprazole (Drug); Esomeprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen-Cilag Pty Ltd Official(s) and/or principal investigator(s): Janssen-Cilag Pty Ltd Clinical Trial, Study Director, Affiliation: Janssen-Cilag Pty Ltd
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.
Clinical Details
Official title: The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: The Number of Patients With Complete Resolution of Heartburn by Week 4The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4 The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4 The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4
Secondary outcome: The Median Time to Complete Resolution of Heartburn Symptoms.The Median Time to Complete Relief of Regurgitation Symptoms The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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
Additional Information
Starting date: November 2006
Last updated: April 2, 2014
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