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

Gastro-oesophageal Reflux Clinical Trial

Official title:

The Rabeprazole and Esomeprazole Reflux Assessment Trial (TREAT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464308
• Other study ID #: CR006397
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2007
• Last updated: April 2, 2014
• Start date: November 2006
• Est. completion date: May 2008

Study information

• Verified date: April 2014
• Source: Janssen-Cilag Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1392
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastro-oesophageal Reflux
• Gastroesophageal Reflux

Intervention

Drug:
• Esomeprazole
20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
• Rabeprazole
20mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily
• Esomeprazole
40mg once daily for 28days - 1 placebo tab/cap & 1 active tab/cap daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Patients With Complete Resolution of Heartburn by Week 4	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.	week 4 of treatment	No
Primary	The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4	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.	4 weeks	No
Primary	The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4	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.	4 weeks	No
Primary	The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4	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.	4 weeks	No
Secondary	The Median Time to Complete Resolution of Heartburn Symptoms.		week 4 of treatment	No
Secondary	The Median Time to Complete Relief of Regurgitation Symptoms		4 weeks	No
Secondary	The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods		4 weeks	No