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

The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,392 (actual)
• Sponsor: Janssen-Cilag Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastro-oesophageal Reflux

Interventions

Type	Name	Description
DRUG	Esomeprazole	20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily
DRUG	Rabeprazole	20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily
DRUG	Esomeprazole	40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-04-23
• Last updated: 2014-04-21
• Results posted: 2010-08-30

Locations

25 sites across 1 country: Australia