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 - Full Text View

Sponsored by:	Janssen-Cilag Pty Ltd
Information provided by:	Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier:	NCT00464308

Purpose

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.

Condition	Intervention	Phase
Gastro-Oesophageal Reflux	Drug: Rabeprazole; Esomeprazole	Phase IV

MedlinePlus related topics: Esophagus Disorders GERD Heartburn

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium E 3810

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)

Further study details as provided by Janssen-Cilag Pty Ltd:

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.

Estimated Enrollment:	1908
Study Start Date:	November 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464308

Contacts

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:

info1@veritasmedicine.com

Locations

Australia
Warringah Mall 24H. Medical Centre	Active, not recruiting
Brookvale, Australia, 2100
Dapto Medical Centre	Active, not recruiting
Dapto, Australia, 2530
Campbelltown Medical & Dental Centre	Active, not recruiting
Campbelltown, Australia, 2560
Ingleburn Medical & Dental Centre	Active, not recruiting
Ingleburn, Australia, 2565
Castle Towers Primary Health Care	Recruiting
Castle Hill, Australia, 2154
Contact: Minoo Ebrahimi +61285502400
Principal Investigator: Minoo Ebrahimi
Marion Domain Medical & Dental Centre	Recruiting
Oaklands Park, Australia, 5046
Contact: Soraya Felix +61883757000
Principal Investigator: Soraya Felix
Wentworthville Medical Centre	Active, not recruiting
Wentworthville, Australia, 2145
Western Plains Medical Centre	Active, not recruiting
Dubbo, Australia, 2830
Caringbah Medical & Dental Centre	Active, not recruiting
Caringbah, Australia, 2229
Fairfield Chase Medical & Dental Centre	Active, not recruiting
Fairfield, Australia, 2165
Darlinghurst Medical & Dental Centre	Active, not recruiting
Darlinghurst, Australia, 2010
Sydney Medical Centre	Active, not recruiting
Sydney, Australia, 2000
Wyoming Medical & Dental Centre	Active, not recruiting
Wyoming, Australia, 2250
Primary Medical & Dental Centre	Active, not recruiting
Melton, Australia, 3337
Bondi Junction Medical & Dental Centre	Active, not recruiting
Bondi Junction, Australia, 2022
Primary Health Care & Medical Centre Werribee Plaza	Active, not recruiting
Hoppers Crossing, Australia, 3029
Campsie Medical & Dental Centre	Active, not recruiting
Campsie, Australia, 2194
Elizabeth Medical & Dental centre	Active, not recruiting
Elizabeth, Australia, 5112
Charlestown Medical & Dental Centre	Recruiting
Charlestown, Australia, 2290
Contact: Helen Hopkins +61249151222
Principal Investigator: Helen Hopkins
Ginninderra Medical and Dental Centre	Active, not recruiting
Belconnen, Australia, 2617
Leichhardt Medical & Dental Centre	Active, not recruiting
Leichhardt, Australia, 2040
Primary Old Port Road Medical & Dental Centre	Recruiting
Royal Park, Australia, 5014
Contact: Stuart Lynch +61884470000
Principal Investigator: Stuart Lynch
Primary Medical & Dental Centre Browns Plains	Recruiting
Browns Plains, Australia, 4118
Contact: Zohra Ismail +61733800111
Principal Investigator: Zohra Ismail
Mt Druitt Medical & Dental Centre	Active, not recruiting
Mount Druitt, Australia, 2770
Maroubra Medical & Dental Centre	Recruiting
Maroubra, Australia, 2035
Contact: Richard Ng +61293499000
Principal Investigator: Richard Ng

Sponsors and Collaborators

Janssen-Cilag Pty Ltd

Investigators

Study Director:

Janssen-Cilag Pty Ltd Clinical Trial

Janssen-Cilag Pty Ltd

More Information

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	CR006397
Study First Received:	April 20, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00464308
Health Authority:	Australia: Department of Health

Keywords provided by Janssen-Cilag Pty Ltd:

Proton pump inhibitor
Heartburn
Gastroesophageal Reflux
GORD

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Pyrosis
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Heartburn
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux
Rabeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009