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

April 2, 2014 updated by: Janssen-Cilag Pty Ltd

The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1392

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 001
Esomeprazole 40mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Drug: Esomeprazole
20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Drug: Esomeprazole
40mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Active Comparator: 002
Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Drug: Esomeprazole
20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Drug: Esomeprazole
40mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Active Comparator: 003
Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Drug: Rabeprazole
20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Patients With Complete Resolution of Heartburn by Week 4
Time Frame: week 4 of treatment
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.
week 4 of treatment
The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4
Time Frame: 4 weeks
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.
4 weeks
The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4
Time Frame: 4 weeks
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.
4 weeks
The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4
Time Frame: 4 weeks
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The Median Time to Complete Resolution of Heartburn Symptoms.
Time Frame: week 4 of treatment
week 4 of treatment
The Median Time to Complete Relief of Regurgitation Symptoms
Time Frame: 4 weeks
4 weeks
The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag Pty Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

April 20, 2007

First Submitted That Met QC Criteria

April 20, 2007

First Posted (Estimate)

April 23, 2007

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR006397

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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