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Tracking Information | |||||
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First Received Date † | April 20, 2007 | ||||
Last Updated Date | April 16, 2009 | ||||
Start Date † | November 2006 | ||||
Current 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. [ Time Frame: week 4 of treatment ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00464308 on ClinicalTrials.gov Archive Site | ||||
Current 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. [ Time Frame: week 4 of treatment ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief 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 Esomeprazole 40m | ||||
Official Title † | The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT) | ||||
Brief 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. |
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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. |
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Gastro-Oesophageal Reflux | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | Eggleston A, Katelaris PH, Nandurkar S, Thorpe P, Holtmann G; Treat Study Group. Clinical trial: the treatment of gastro-oesophageal reflux disease in primary care--prospective randomized comparison of rabeprazole 20 mg with esomeprazole 20 and 40 mg. Aliment Pharmacol Ther. 2009 May 1;29(9):967-78. Epub 2009 Feb 3. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 1392 | ||||
Completion Date | May 2008 | ||||
Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00464308 | ||||
Responsible Party | Exec. Director Medical & Scientific Affairs J-C, Janssen-Cilag Pty Ltd | ||||
Secondary IDs †† | RABGRD4009 | ||||
Study Sponsor † | Janssen-Cilag Pty Ltd | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Janssen-Cilag Pty Ltd | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |