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.

Official 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 Esomperazole 40m

Conditions

Gastro-Oesophageal Reflux

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• The proportion of patients with complete resolution of heartburn and regurgitation by week 4 of treatment and the proportion of patients with satisfactory resolution of heartburn and regurgitation by week 4 of treatment.

Secondary Outcome Measures:

• The proportion of patients with complete resolution and satisfactory resolution of other GORD symptoms by week 4 of treatment. The median time to first symptom resolution and heartburn and regurgitation frequency.

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 centres, treatment is assigned based on chance (randomised), similar to the toss of a coin and neither doctor or patient knows which treatment they will received (double-blinded). Following screening to determine eligibility, patients will be randomised 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 hypothesised 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 Start

November 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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 appendicetomy 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

Total Enrolment

1908

Contact Details

Wyoming Medical & Dental Centre, Wyoming, 2250, Australia; Recruiting

• Mark Fairbrother +61243299000

Mt Druitt Medical & Dental Centre, Mt. Druitt, 2770, Australia; Recruiting

• Len Yudeiken +61298322424

Primary Medical & Dental Centre Browns Plains, Browns Plains, 4118, Australia; Recruiting

• Zohra Ismail +61733800111

Narregate Medical & Dental Centre, Narre Warren, 3805, Australia; Active, not recruitingPrimary Old Port Road Medical & Dental Centre, Royal Park, 5014, Australia; Recruiting

• Stuart Lynch +61884470000

Leichhardt Medical & Dental Centre, Leichhardt, 2040, Australia; Recruiting

• Damian Lindall +61295613333

Primary Health Care Medical and Dental Centre, Bankstown, 2200, Australia; Active, not recruiting Ginninderra Medical and Dental Centre, Belconnen, 2617, Australia; Recruiting

• Philip Barraclough +61261127111

Charlestown Medical & Dental Centre, Charlestown, 2290, Australia; Recruiting

• Helen Hopkins +61249151222

Elizabeth Medical & Dental centre, Elizabeth, 5112, Australia; Recruiting

• Nick Boon +61882568000

Campsie Medical & Dental Centre, Campsie, 2194, Australia; Recruiting

• Malathi Waran +61297877724

Primary Health Care & Medical Centre Werribee Plaza, Hoopers Crossing, 3029, Australia; Recruiting

• Anthony Farnbach +61387340333

Bondi Junction Medical & Dental Centre, Bondi Junction, 2022, Australia; Recruiting

• Harry Johnson +61283057777

Primary Medical & Dental Centre, Melton, 3337, Australia; Recruiting

• Peter Rankin +61387460200

Maroubra Medical & Dental Centre, Maroubra, 2035, Australia; Recruiting

• Richard Ng +61293499000

Eureka Medical and Dental Centre, Ballarat, 3350, Australia; Active, not recruiting Sydney Medical Centre, Sydney, 2000, Australia; Active, not recruiting Darlinghurst Medical & Dental Centre, Darlinghurst, 2010, Australia; Recruiting

• Joseph Grech +61283021111

Fairfield Chase Medical & Dental Centre, Fairfield, 2165, Australia; Recruiting

• Harry Pope +61297235555

Caringbah, Caringbah, 2229, Australia; Recruiting

• Alan Saunders +61295259477

Western Plains Medical Centre, Dubbo, 2830, Australia; Recruiting

• David Gibson +61268419000

Wentworthville Medical Centre, Wentworthville, 2145, Australia; Recruiting

• Raymond Morsingh +61288683800

Marion Domain Medical & Dental Centre, Oaklands Park, 5046, Australia; Recruiting

• Soraya Felix +61883757000

Norwood Village Medical & Dental Centre, Norwood, 5067, Australia; Active, not recruiting Chatswood 24Hr Medical Centre, Chatswood, 2067, Australia; Active, not recruiting Castle Towers Primary Health Care, Castle Hill, 2154, Australia; Recruiting

• Minoo Ebrahimi +61285502400

Ingleburn Medical & Dental Centre, Ingleburn, 2565, Australia; Recruiting

• Tuan Tran +61298292900

Campbelltown, Campbelltown, 2560, Australia; Recruiting

• Martin Baker +61246283777

Dapto Medical Centre, Dapto, 2530, Australia; Recruiting Warringah Mall 24H. Medical Centre, Brookvale, 2100, Australia; Recruiting

• Themi Garagounis +61299386666

To learn how to participate in this trial, click here