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

NCT00464308 | Completed Phase 4 Results

• 1 other identifier: CR006397
• Study Type: interventional
• Target: 1,392
• Locations: 1 country
• Sites: 25

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.

Conditions

Gastro-oesophageal Reflux

Keywords

Gastroesophageal Reflux; Heartburn; Proton pump inhibitor; GORD

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (3)

• The Median Time to Complete Resolution of Heartburn Symptoms.

  week 4 of treatment

• The Median Time to Complete Relief of Regurgitation Symptoms

  4 weeks

• The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods

  4 weeks

Study Arms (3)

001

ACTIVE COMPARATOR

Esomeprazole 40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Drug: Esomeprazole

002

ACTIVE COMPARATOR

Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Drug: Esomeprazole

003

ACTIVE COMPARATOR

Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Drug: Rabeprazole

Interventions

Esomeprazole DRUG

20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

002

Rabeprazole DRUG

20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

003

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Pty Ltd: lead

Study Sites (25)

Unknown Facility

Belconnen, Australia

Location

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Bondi Junction, Australia

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Brookvale, Australia

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Browns Plains, Australia

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Campbelltown, Australia

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Campsie, Australia

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Caringbah, Australia

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Castle Hill, Australia

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Charlestown, Australia

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Dapto, Australia

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Darlinghurst, Australia

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Dubbo, Australia

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Elizabeth, Australia

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Fairfield, Australia

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Hoppers Crossing, Australia

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Ingleburn, Australia

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Leichhardt, Australia

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Maroubra, Australia

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Melton, Australia

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Mount Druitt, Australia

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Oaklands Park, Australia

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Royal Park, Australia

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Sydney, Australia

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Wentworthville, Australia

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Wyoming, Australia

Location

Related Publications (2)

• Biscola FT, Abe CM, Guth BE. Determination of adhesin gene sequences in, and biofilm formation by, O157 and non-O157 Shiga toxin-producing Escherichia coli strains isolated from different sources. Appl Environ Microbiol. 2011 Apr;77(7):2201-8. doi: 10.1128/AEM.01920-10. Epub 2011 Feb 11.

  PMID: 21317257 DERIVED

• 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. doi: 10.1111/j.1365-2036.2009.03948.x. Epub 2009 Feb 3.

  PMID: 19210493 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

Esomeprazole; Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The MCID of 7.5% was amended to 9% to maintain power with smaller sample size.The proportion of patients without heartburn symptoms at baseline was not evenly distributed between treatment arms. This was a significant predictor of symptom resolution.

Results Point of Contact

• Title: Executive Director, Medical & Scientific Affairs
• Organization: Janssen-Cilag Pty Ltd

mhandel@its.jnj.com

+61 2 9815 3219

Study Officials

• Janssen-Cilag Pty Ltd Clinical Trial

  Janssen-Cilag Pty Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: November 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 21, 2014
• Results First Posted: August 30, 2010

Record last verified: 2014-04

Locations

AU (25)