Clinical trial NCT00464308: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastro-oesophageal Reflux
Keywords: Gastroesophageal Reflux
Heartburn
Proton pump inhibitor
GORD
Lead sponsor: Janssen-Cilag Pty Ltd
Sponsor class: INDUSTRY
First posted: 2007-04-23
Enrollment: 1392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Number of Patients With Complete Resolution of Heartburn by Week 4
timeFrame: week 4 of treatment
measure: The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4
timeFrame: 4 weeks
measure: The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4
timeFrame: 4 weeks
measure: The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4
timeFrame: 4 weeks
Secondary outcomes:
measure: The Median Time to Complete Resolution of Heartburn Symptoms.
timeFrame: week 4 of treatment
measure: The Median Time to Complete Relief of Regurgitation Symptoms
timeFrame: 4 weeks
measure: The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods
timeFrame: 4 weeks
Other outcomes:
Locations:
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
Study officials:
affiliation: Janssen-Cilag Pty Ltd
name: Janssen-Cilag Pty Ltd Clinical Trial
role: STUDY_DIRECTOR
References:
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.
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.