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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
This study has been completed.
Study NCT00464308   Information provided by Janssen-Cilag Pty Ltd
First Received: April 20, 2007   Last Updated: April 16, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

April 20, 2007
April 16, 2009
November 2006
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 ]
Same as current
Complete list of historical versions of study NCT00464308 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
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
The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Gastro-Oesophageal Reflux
  • Drug: Esomeprazole
  • Drug: Rabeprazole
 
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.
 
Completed
1392
May 2008
May 2008   (final data collection date for primary outcome measure)

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 appendectomy 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
Both
18 Years and older
No
 
 
 
 
NCT00464308
Exec. Director Medical & Scientific Affairs J-C, Janssen-Cilag Pty Ltd
RABGRD4009
Janssen-Cilag Pty Ltd
 
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
Janssen-Cilag Pty Ltd
April 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.