Back to resultsA 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
Primary Purpose
Gastro-oesophageal Reflux
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Esomeprazole
Rabeprazole
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Gastro-oesophageal Reflux focused on measuring Gastroesophageal Reflux, Heartburn, Proton pump inhibitor, GORD
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
001
002
003
Arm Description
Esomeprazole 40mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00464308
Brief Title
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
Official Title
The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Pty Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-oesophageal Reflux
Keywords
Gastroesophageal Reflux, Heartburn, Proton pump inhibitor, GORD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1392 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Active Comparator
Arm Description
Esomeprazole 40mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Arm Title
002
Arm Type
Active Comparator
Arm Description
Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Arm Title
003
Arm Type
Active Comparator
Arm Description
Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Intervention Description
20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
40mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Primary Outcome Measure Information:
Title
The Number of Patients With Complete Resolution of Heartburn by Week 4
Description
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
Title
The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4
Description
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
Title
The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4
Description
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
Title
The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4
Description
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
Secondary Outcome Measure Information:
Title
The Median Time to Complete Resolution of Heartburn Symptoms.
Time Frame
week 4 of treatment
Title
The Median Time to Complete Relief of Regurgitation Symptoms
Time Frame
4 weeks
Title
The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Pty Ltd Clinical Trial
Organizational Affiliation
Janssen-Cilag Pty Ltd
Official's Role
Study Director
Facility Information:
City
Belconnen
Country
Australia
City
Bondi Junction
Country
Australia
City
Brookvale
Country
Australia
City
Browns Plains
Country
Australia
City
Campbelltown
Country
Australia
City
Campsie
Country
Australia
City
Caringbah
Country
Australia
City
Castle Hill
Country
Australia
City
Charlestown
Country
Australia
City
Dapto
Country
Australia
City
Darlinghurst
Country
Australia
City
Dubbo
Country
Australia
City
Elizabeth
Country
Australia
City
Fairfield
Country
Australia
City
Hoppers Crossing
Country
Australia
City
Ingleburn
Country
Australia
City
Leichhardt
Country
Australia
City
Maroubra
Country
Australia
City
Melton
Country
Australia
City
Mount Druitt
Country
Australia
City
Oaklands Park
Country
Australia
City
Royal Park
Country
Australia
City
Sydney
Country
Australia
City
Wentworthville
Country
Australia
City
Wyoming
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
21317257
Citation
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.
Results Reference
derived
PubMed Identifier
19210493
Citation
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.
Results Reference
derived
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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
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