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Sponsored by: |
Janssen-Cilag Pty Ltd |
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Information provided by: | Janssen-Cilag Pty Ltd |
ClinicalTrials.gov Identifier: | NCT00464308 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT) |
Estimated Enrollment: | 1908 |
Study Start Date: | November 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Study Director: | Janssen-Cilag Pty Ltd Clinical Trial | Janssen-Cilag Pty Ltd |
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 |
Proton pump inhibitor Heartburn Gastroesophageal Reflux GORD |
Deglutition Disorders Esophageal Motility Disorders Pyrosis Digestive System Diseases Esophageal disorder Gastrointestinal Diseases |
Heartburn Omeprazole Esophageal Diseases Gastroesophageal Reflux Rabeprazole |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |