Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000006448
Ethics application status
Approved
Date submitted
8/12/2006
Date registered
5/01/2007
Date last updated
2/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Rabeprazole and Esomeprazole Reflux Assessment Trial
Scientific title
A multicentre, double blind, randomised controlled non-inferiority study to compare the number of subjects with gastro-oesophageal reflux disease achieving heartburn and regurgitation symptom resolution after treatment with either Rabeprazole Sodium (PARIET) 20mg, Esomeprazole (NEXIUM) 20mg or Esomeprazole (NEXIUM) 40mg
Universal Trial Number (UTN)
Trial acronym
TREAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro-oesophageal reflux disease 1509 0
Condition category
Condition code
Physical Medicine / Rehabilitation 1607 1607 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
Subjects will be randomised to receive oral treatment with either 20mg Rabeprazole Sodium (PARIET), 20mg Esomeprazole (NEXIUM) or 40mg Esomeprazole (NEXIUM) once daily for 4 weeks. There is no control group all treatments are currently marketing active interventions.
Intervention code [1] 1493 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Active

Outcomes
Primary outcome [1] 2216 0
The primary objective of this study is to compare in a non-inferiority design, the number of subjects with heartburn and regurgitation symptom resolution after 4 weeks of treatment with either rabeprazole 20mg, esomeprazole 20mg or esomeprazole 40mg. The degree of resolution will be defined as follows:
1. Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period
2. Satisfactory resolution is a reduction in symptom severity from moderate, severe or very severe to mild, very mild or none at any time within the 4 week period.
Timepoint [1] 2216 0
Subjects assess symptom response daily with degree of resolution measured at week 4
Secondary outcome [1] 3862 0
1. Comparison of the number of subjects in each treatment group with resolution of other GORD symptoms, measured daily (fullness/ early satiety, nausea/ vomiting, bloating, upper abdominal pain and lower abdominal pain) where the degree of resolution will be defined as Complete or Satisfactory Resolution.
Timepoint [1] 3862 0
Measured at week 4
Secondary outcome [2] 3863 0
2. Comparison of the median time to first symptom resolution
Timepoint [2] 3863 0
Measured on a daily basis through patient self-evaluation until week 4.
Secondary outcome [3] 3864 0
3. Comparison of the number of heartburn and regurgitation symptom free days
Timepoint [3] 3864 0
Measured on a daily basis through patient self-evaluation until week 4.
Secondary outcome [4] 3865 0
4. Evaluation of the severity of symptoms during treatment.
Timepoint [4] 3865 0
Measured on a daily basis through patient self-evaluation until week 4.
Secondary outcome [5] 3866 0
5. Comparison of changes in Quality of Life between the three treatment groups.
Timepoint [5] 3866 0
Quality of Life is measured at Baseline and Week 4
Secondary outcome [6] 3867 0
6. Comparison of subject and investigator satisfaction.
Timepoint [6] 3867 0
Satisfaction measured at week 4 and compared between the 3 groups.
Secondary outcome [7] 3868 0
7. Analysis of factors predictive of outcomes·
Timepoint [7] 3868 0
patients will be evaluated once at baseline and once at the end of the 4 weeks. The patients will self-evaluate symptom resolution on a daily basis throughout the 4 weeks.
Secondary outcome [8] 3869 0
8. Evaluation of safety and tolerability of treatments
Timepoint [8] 3869 0
patients will be evaluated once at baseline and once at the end of the 4 weeks.

Eligibility
Key inclusion criteria
1. Able to give written informed consent. 2. 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. To be eligible, subjects 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. 3. Able to understand and complete questionnaires and have access to a telephone. 4. Helicobacter pylori testing is allowed provided that it is not critical to a PPI-prescribing decision and(a) The results of the test must not be divulged to the subject(b) No interventions as a result of the test occur until after the subject’s participation in the study.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects 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. These would include, but are not limited to, alarm symptoms such as unintentional weight loss, progressive difficulty swallowing (dysphagia), iron deficiency anaemia and epigastric mass.2. Significant gastrointestinal disease active in the last 12 months including:i) GI bleedingii) Gastroduodenal ulceriii) Infectious or inflammatory conditions of the intestineiv) Functional dyspepsiav) Malabsorption syndromesvi) Gastrointestinal obstructionvii) Major gastric or oesophageal surgery (excluding appendicectomy or cholecystectomy)viii) Oesophageal stricture or pyloric stenosisix) Extra-oesophageal manifestations of reflux disease3. Barrett's oesophagus (>3cm)4. Zollinger-Ellison Syndrome5. Scleroderma6. Malignancy (other than non-melanoma skin cancers) present within the last 5-years7. Subjects with a known hypersensitivity to rabeprazole or esomeprazole or any PPI8. Female subjects who are currently pregnant or breastfeeding, or who, in the opinion of the investigator, may become pregnant throughout the study9. Use of:i) histamine-2 receptor antagonists (H2RAs) within 7 days of randomisationii) 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.Note – subjects on stable doses of anticholinergics, cholinergics, spasmolytics, opiates and NSAIDs are eligible for entry (where stable dose is defined as one unchanged for > 1 month prior to screening)iii) any drug contra-indicated for use with PPIs10. Any other significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study e.g. past or current history of alcohol or drug abuse, hepatic, renal, pulmonary, respiratory abnormalities etc11. Subjects who are unwilling or unable to abide by the requirements of the study (e.g. completion of daily diary, attendance at study visits)12. Subjects 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.

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)
Numbered Containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The following are blinded throughout the study - Subjects, Clinicians, Primary Clinical Research Organisation (CRO), Data Analysts and Sponsor
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1908
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1751 0
Commercial sector/Industry
Name [1] 1751 0
Janssen-Cilag Pty Ltd
Country [1] 1751 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Janssen-Cilag Pty Ltd
Address
1-5 Khartoum Rd
North Ryde NSW 2113
Country
United Kingdom
Secondary sponsor category [1] 1552 0
None
Name [1] 1552 0
Nil
Address [1] 1552 0
Country [1] 1552 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3247 0
Eureka Medical & Dental Centre
Ethics committee address [1] 3247 0
Ethics committee country [1] 3247 0
Australia
Date submitted for ethics approval [1] 3247 0
Approval date [1] 3247 0
09/10/2006
Ethics approval number [1] 3247 0
NREEC 06/14
Ethics committee name [2] 3248 0
Primary Health Care Medical & Dental Centre
Ethics committee address [2] 3248 0
Ethics committee country [2] 3248 0
Australia
Date submitted for ethics approval [2] 3248 0
Approval date [2] 3248 0
Ethics approval number [2] 3248 0
Ethics committee name [3] 3249 0
Ginninderra Medical & Dental Centre
Ethics committee address [3] 3249 0
Ethics committee country [3] 3249 0
Australia
Date submitted for ethics approval [3] 3249 0
Approval date [3] 3249 0
Ethics approval number [3] 3249 0
Ethics committee name [4] 3250 0
Bondi Junction Medical & Dental Centre
Ethics committee address [4] 3250 0
Ethics committee country [4] 3250 0
Australia
Date submitted for ethics approval [4] 3250 0
Approval date [4] 3250 0
Ethics approval number [4] 3250 0
Ethics committee name [5] 3251 0
Warringah Mall 24Hr. Medical Centre
Ethics committee address [5] 3251 0
Ethics committee country [5] 3251 0
Australia
Date submitted for ethics approval [5] 3251 0
Approval date [5] 3251 0
Ethics approval number [5] 3251 0
Ethics committee name [6] 3252 0
Primary Medical & Dental Centre Browns Plains
Ethics committee address [6] 3252 0
Ethics committee country [6] 3252 0
Australia
Date submitted for ethics approval [6] 3252 0
Approval date [6] 3252 0
Ethics approval number [6] 3252 0
Ethics committee name [7] 3253 0
Campbelltown Medical & Dental Centre
Ethics committee address [7] 3253 0
Ethics committee country [7] 3253 0
Australia
Date submitted for ethics approval [7] 3253 0
Approval date [7] 3253 0
Ethics approval number [7] 3253 0
Ethics committee name [8] 3254 0
Campsie Medical & Dental Centre
Ethics committee address [8] 3254 0
Ethics committee country [8] 3254 0
Australia
Date submitted for ethics approval [8] 3254 0
Approval date [8] 3254 0
Ethics approval number [8] 3254 0
Ethics committee name [9] 3255 0
Caringbah Medical & Dental Centre
Ethics committee address [9] 3255 0
Ethics committee country [9] 3255 0
Australia
Date submitted for ethics approval [9] 3255 0
Approval date [9] 3255 0
Ethics approval number [9] 3255 0
Ethics committee name [10] 3256 0
Castle Towers Primary Health Centre
Ethics committee address [10] 3256 0
Ethics committee country [10] 3256 0
Australia
Date submitted for ethics approval [10] 3256 0
Approval date [10] 3256 0
Ethics approval number [10] 3256 0
Ethics committee name [11] 3257 0
Charlestown Medical & Dental Centre
Ethics committee address [11] 3257 0
Ethics committee country [11] 3257 0
Australia
Date submitted for ethics approval [11] 3257 0
Approval date [11] 3257 0
Ethics approval number [11] 3257 0
Ethics committee name [12] 3258 0
Chatswood 24Hr. Medical Centre
Ethics committee address [12] 3258 0
Ethics committee country [12] 3258 0
Australia
Date submitted for ethics approval [12] 3258 0
Approval date [12] 3258 0
Ethics approval number [12] 3258 0
Ethics committee name [13] 3259 0
Sydney Medical Centre
Ethics committee address [13] 3259 0
Ethics committee country [13] 3259 0
Australia
Date submitted for ethics approval [13] 3259 0
Approval date [13] 3259 0
Ethics approval number [13] 3259 0
Ethics committee name [14] 3260 0
Dapto Medical Centre
Ethics committee address [14] 3260 0
Ethics committee country [14] 3260 0
Australia
Date submitted for ethics approval [14] 3260 0
Approval date [14] 3260 0
Ethics approval number [14] 3260 0
Ethics committee name [15] 3261 0
Darlinghurst Medical Centre
Ethics committee address [15] 3261 0
Ethics committee country [15] 3261 0
Australia
Date submitted for ethics approval [15] 3261 0
Approval date [15] 3261 0
Ethics approval number [15] 3261 0
Ethics committee name [16] 3262 0
Western Plains Medical Centre
Ethics committee address [16] 3262 0
Ethics committee country [16] 3262 0
Australia
Date submitted for ethics approval [16] 3262 0
Approval date [16] 3262 0
Ethics approval number [16] 3262 0
Ethics committee name [17] 3263 0
Elizabeth Medical & Dental Centre
Ethics committee address [17] 3263 0
Ethics committee country [17] 3263 0
Australia
Date submitted for ethics approval [17] 3263 0
Approval date [17] 3263 0
Ethics approval number [17] 3263 0
Ethics committee name [18] 3264 0
Fairfield Chase Medical & Dental Centre
Ethics committee address [18] 3264 0
Ethics committee country [18] 3264 0
Australia
Date submitted for ethics approval [18] 3264 0
Approval date [18] 3264 0
Ethics approval number [18] 3264 0
Ethics committee name [19] 3265 0
Ingleburn Medical Centre
Ethics committee address [19] 3265 0
Ethics committee country [19] 3265 0
Australia
Date submitted for ethics approval [19] 3265 0
Approval date [19] 3265 0
Ethics approval number [19] 3265 0
Ethics committee name [20] 3266 0
Leichhardt Medical & Dental Centre
Ethics committee address [20] 3266 0
Ethics committee country [20] 3266 0
Australia
Date submitted for ethics approval [20] 3266 0
Approval date [20] 3266 0
Ethics approval number [20] 3266 0
Ethics committee name [21] 3267 0
Marion Domain Medical & Dental Centre
Ethics committee address [21] 3267 0
Ethics committee country [21] 3267 0
Australia
Date submitted for ethics approval [21] 3267 0
Approval date [21] 3267 0
Ethics approval number [21] 3267 0
Ethics committee name [22] 3268 0
Maroubra Medical & Dental Centre
Ethics committee address [22] 3268 0
Ethics committee country [22] 3268 0
Australia
Date submitted for ethics approval [22] 3268 0
Approval date [22] 3268 0
Ethics approval number [22] 3268 0
Ethics committee name [23] 3269 0
Primary Medical & Dental Centre, Melton
Ethics committee address [23] 3269 0
Ethics committee country [23] 3269 0
Australia
Date submitted for ethics approval [23] 3269 0
Approval date [23] 3269 0
Ethics approval number [23] 3269 0
Ethics committee name [24] 3270 0
Mt. Druitt Medical & Dental Centre
Ethics committee address [24] 3270 0
Ethics committee country [24] 3270 0
Australia
Date submitted for ethics approval [24] 3270 0
Approval date [24] 3270 0
Ethics approval number [24] 3270 0
Ethics committee name [25] 3271 0
Narregate Medical & Dental Centre
Ethics committee address [25] 3271 0
Ethics committee country [25] 3271 0
Australia
Date submitted for ethics approval [25] 3271 0
Approval date [25] 3271 0
Ethics approval number [25] 3271 0
Ethics committee name [26] 3272 0
Norwood Village Medical & Dental Centre
Ethics committee address [26] 3272 0
Ethics committee country [26] 3272 0
Australia
Date submitted for ethics approval [26] 3272 0
Approval date [26] 3272 0
Ethics approval number [26] 3272 0
Ethics committee name [27] 3273 0
Primary Old Port Road Medical & Dental Centre
Ethics committee address [27] 3273 0
Ethics committee country [27] 3273 0
Australia
Date submitted for ethics approval [27] 3273 0
Approval date [27] 3273 0
Ethics approval number [27] 3273 0
Ethics committee name [28] 3274 0
Wentworthville Medical Centre
Ethics committee address [28] 3274 0
Ethics committee country [28] 3274 0
Australia
Date submitted for ethics approval [28] 3274 0
Approval date [28] 3274 0
Ethics approval number [28] 3274 0
Ethics committee name [29] 3275 0
Primary Health Care Medical & Dental Centre Werribee Plaza
Ethics committee address [29] 3275 0
Ethics committee country [29] 3275 0
Australia
Date submitted for ethics approval [29] 3275 0
Approval date [29] 3275 0
Ethics approval number [29] 3275 0
Ethics committee name [30] 3276 0
Wyoming Medical & Dental Centre
Ethics committee address [30] 3276 0
Ethics committee country [30] 3276 0
Australia
Date submitted for ethics approval [30] 3276 0
Approval date [30] 3276 0
Ethics approval number [30] 3276 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27427 0
Address 27427 0
Country 27427 0
Phone 27427 0
Fax 27427 0
Email 27427 0
Contact person for public queries
Name 10682 0
Gladys Williams
Address 10682 0
C/- Pretium
Country 10682 0
Australia
Phone 10682 0
+61 (0)439 001 492
Fax 10682 0
Email 10682 0
Gladys.Williams@pretium.com.au
Contact person for scientific queries
Name 1610 0
Munro Neville
Address 1610 0
C/-Pretium
Country 1610 0
Australia
Phone 1610 0
+61 2 8257 6570
Fax 1610 0
Email 1610 0
munro.neville@pretium.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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