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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00464308




Registration number
NCT00464308
Ethics application status
Date submitted
20/04/2007
Date registered
23/04/2007
Date last updated
21/04/2014

Titles & IDs
Public 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
Scientific title
The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)
Secondary ID [1] 0 0
CR006397
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro-oesophageal Reflux 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Esomeprazole
Treatment: Drugs - Rabeprazole
Treatment: Drugs - Esomeprazole

Active Comparator: 001 - 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

Active Comparator: 003 - Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily


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

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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
week 4 of treatment
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
4 weeks
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
4 weeks
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
4 weeks
Secondary outcome [1] 0 0
The Median Time to Complete Resolution of Heartburn Symptoms.
Timepoint [1] 0 0
week 4 of treatment
Secondary outcome [2] 0 0
The Median Time to Complete Relief of Regurgitation Symptoms
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods
Timepoint [3] 0 0
4 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Belconnen
Recruitment hospital [2] 0 0
- Bondi Junction
Recruitment hospital [3] 0 0
- Brookvale
Recruitment hospital [4] 0 0
- Browns Plains
Recruitment hospital [5] 0 0
- Campbelltown
Recruitment hospital [6] 0 0
- Campsie
Recruitment hospital [7] 0 0
- Caringbah
Recruitment hospital [8] 0 0
- Castle Hill
Recruitment hospital [9] 0 0
- Charlestown
Recruitment hospital [10] 0 0
- Dapto
Recruitment hospital [11] 0 0
- Darlinghurst
Recruitment hospital [12] 0 0
- Dubbo
Recruitment hospital [13] 0 0
- Elizabeth
Recruitment hospital [14] 0 0
- Fairfield
Recruitment hospital [15] 0 0
- Hoppers Crossing
Recruitment hospital [16] 0 0
- Ingleburn
Recruitment hospital [17] 0 0
- Leichhardt
Recruitment hospital [18] 0 0
- Maroubra
Recruitment hospital [19] 0 0
- Melton
Recruitment hospital [20] 0 0
- Mount Druitt
Recruitment hospital [21] 0 0
- Oaklands Park
Recruitment hospital [22] 0 0
- Royal Park
Recruitment hospital [23] 0 0
- Sydney
Recruitment hospital [24] 0 0
- Wentworthville
Recruitment hospital [25] 0 0
- Wyoming
Recruitment postcode(s) [1] 0 0
- Belconnen
Recruitment postcode(s) [2] 0 0
- Bondi Junction
Recruitment postcode(s) [3] 0 0
- Brookvale
Recruitment postcode(s) [4] 0 0
- Browns Plains
Recruitment postcode(s) [5] 0 0
- Campbelltown
Recruitment postcode(s) [6] 0 0
- Campsie
Recruitment postcode(s) [7] 0 0
- Caringbah
Recruitment postcode(s) [8] 0 0
- Castle Hill
Recruitment postcode(s) [9] 0 0
- Charlestown
Recruitment postcode(s) [10] 0 0
- Dapto
Recruitment postcode(s) [11] 0 0
- Darlinghurst
Recruitment postcode(s) [12] 0 0
- Dubbo
Recruitment postcode(s) [13] 0 0
- Elizabeth
Recruitment postcode(s) [14] 0 0
- Fairfield
Recruitment postcode(s) [15] 0 0
- Hoppers Crossing
Recruitment postcode(s) [16] 0 0
- Ingleburn
Recruitment postcode(s) [17] 0 0
- Leichhardt
Recruitment postcode(s) [18] 0 0
- Maroubra
Recruitment postcode(s) [19] 0 0
- Melton
Recruitment postcode(s) [20] 0 0
- Mount Druitt
Recruitment postcode(s) [21] 0 0
- Oaklands Park
Recruitment postcode(s) [22] 0 0
- Royal Park
Recruitment postcode(s) [23] 0 0
- Sydney
Recruitment postcode(s) [24] 0 0
- Wentworthville
Recruitment postcode(s) [25] 0 0
- Wyoming

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen-Cilag Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00464308
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen-Cilag Pty Ltd Clinical Trial
Address 0 0
Janssen-Cilag Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications