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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 40mg

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier:
NCT00464308
First received: April 20, 2007
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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: Esomeprazole
Drug: Rabeprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Pty Ltd:

Primary Outcome Measures:
  • The Number of Patients With Complete Resolution of Heartburn by Week 4 [ Time Frame: week 4 of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Median Time to Complete Resolution of Heartburn Symptoms. [ Time Frame: week 4 of treatment ] [ Designated as safety issue: No ]
  • The Median Time to Complete Relief of Regurgitation Symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 1392
Study Start Date: November 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 001
Esomeprazole 40mg 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: 002
Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Drug: Esomeprazole
20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
Active Comparator: 003
Rabeprazole 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464308

Locations
Australia
Belconnen, Australia
Bondi Junction, Australia
Brookvale, Australia
Browns Plains, Australia
Campbelltown, Australia
Campsie, Australia
Caringbah, Australia
Castle Hill, Australia
Charlestown, Australia
Dapto, Australia
Darlinghurst, Australia
Dubbo, Australia
Elizabeth, Australia
Fairfield, Australia
Hoppers Crossing, Australia
Ingleburn, Australia
Leichhardt, Australia
Maroubra, Australia
Melton, Australia
Mount Druitt, Australia
Oaklands Park, Australia
Royal Park, Australia
Sydney, Australia
Wentworthville, Australia
Wyoming, Australia
Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

No publications provided by Janssen-Cilag Pty Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT00464308     History of Changes
Other Study ID Numbers: CR006397
Study First Received: April 20, 2007
Results First Received: June 9, 2009
Last Updated: April 2, 2014
Health Authority: Australia: Department of Health

Keywords provided by Janssen-Cilag Pty Ltd:
Gastroesophageal Reflux
Heartburn
Proton pump inhibitor
GORD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
Rabeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014