We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00464308
First Posted: April 23, 2007
Last Update Posted: April 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen-Cilag Pty Ltd
April 20, 2007
April 23, 2007
June 9, 2009
August 30, 2010
April 21, 2014
November 2006
May 2008   (Final data collection date for primary outcome measure)
  • The Number of Patients With Complete Resolution of Heartburn by Week 4 [ Time Frame: week 4 of treatment ]
    Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.
  • The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4 [ Time Frame: 4 weeks ]
    Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.
  • The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4 [ Time Frame: 4 weeks ]
    Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild) assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.
  • The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4 [ Time Frame: 4 weeks ]
    Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds 'mild' (symptoms must be absent, very mild, or mild)assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.
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.
Complete list of historical versions of study NCT00464308 on ClinicalTrials.gov Archive Site
  • The Median Time to Complete Resolution of Heartburn Symptoms. [ Time Frame: week 4 of treatment ]
  • The Median Time to Complete Relief of Regurgitation Symptoms [ Time Frame: 4 weeks ]
  • The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods [ Time Frame: 4 weeks ]
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.
Not Provided
Not Provided
 
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)
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 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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Gastro-oesophageal Reflux
  • 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
  • Active Comparator: 001
    Esomeprazole 40mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
    Intervention: Drug: Esomeprazole
  • Active Comparator: 002
    Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
    Intervention: Drug: Esomeprazole
  • Active Comparator: 003
    Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
    Intervention: Drug: Rabeprazole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00464308
CR006397
No
Not Provided
Not Provided
Janssen-Cilag Pty Ltd
Janssen-Cilag Pty Ltd
Not Provided
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
Janssen-Cilag Pty Ltd
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP