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 Esomeperazole 40m

Condition(s) targeted: Gastro-Oesophageal Reflux

Intervention: Rabeprazole; Esomeprazole (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Janssen-Cilag Pty Ltd

Official(s) and/or principal investigator(s):
Janssen-Cilag Pty Ltd Clinical Trial, Study Director, Affiliation: Janssen-Cilag Pty Ltd

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

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: The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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: 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.

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 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 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

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Warringah Mall 24H. Medical Centre, Brookvale 2100, Australia; Active, not recruiting

Dapto Medical Centre, Dapto 2530, Australia; Active, not recruiting

Campbelltown Medical & Dental Centre, Campbelltown 2560, Australia; Active, not recruiting

Ingleburn Medical & Dental Centre, Ingleburn 2565, Australia; Active, not recruiting

Castle Towers Primary Health Care, Castle Hill 2154, Australia; Active, not recruiting

Marion Domain Medical & Dental Centre, Oaklands Park 5046, Australia; Recruiting
Soraya Felix, Phone: +61883757000
Soraya Felix, Principal Investigator

Wentworthville Medical Centre, Wentworthville 2145, Australia; Active, not recruiting

Western Plains Medical Centre, Dubbo 2830, Australia; Active, not recruiting

Caringbah Medical & Dental Centre, Caringbah 2229, Australia; Active, not recruiting

Fairfield Chase Medical & Dental Centre, Fairfield 2165, Australia; Active, not recruiting

Darlinghurst Medical & Dental Centre, Darlinghurst 2010, Australia; Active, not recruiting

Sydney Medical Centre, Sydney 2000, Australia; Active, not recruiting

Maroubra Medical & Dental Centre, Maroubra 2035, Australia; Active, not recruiting

Primary Medical & Dental Centre, Melton 3337, Australia; Active, not recruiting

Bondi Junction Medical & Dental Centre, Bondi Junction 2022, Australia; Active, not recruiting

Primary Health Care & Medical Centre Werribee Plaza, Hoppers Crossing 3029, Australia; Active, not recruiting

Campsie Medical & Dental Centre, Campsie 2194, Australia; Active, not recruiting

Elizabeth Medical & Dental centre, Elizabeth 5112, Australia; Active, not recruiting

Charlestown Medical & Dental Centre, Charlestown 2290, Australia; Active, not recruiting

Ginninderra Medical and Dental Centre, Belconnen 2617, Australia; Active, not recruiting

Leichhardt Medical & Dental Centre, Leichhardt 2040, Australia; Active, not recruiting

Primary Old Port Road Medical & Dental Centre, Royal Park 5014, Australia; Recruiting
Stuart Lynch, Phone: +61884470000
Stuart Lynch, Principal Investigator

Primary Medical & Dental Centre Browns Plains, Browns Plains 4118, Australia; Recruiting
Zohra Ismail, Phone: +61733800111
Zohra Ismail, Principal Investigator

Mt Druitt Medical & Dental Centre, Mount Druitt 2770, Australia; Active, not recruiting

Wyoming Medical & Dental Centre, Wyoming 2250, Australia; Active, not recruiting

To learn how to participate in this trial please click here.

Starting date: November 2006
Last updated: January 29, 2009