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.

Study NCT00464308 Information provided by Janssen-Cilag Pty Ltd

First Received on April 20, 2007. Last Updated on August 26, 2010 History of Changes

Results First Received: June 9, 2009

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
Condition:	Gastro-oesophageal Reflux
Interventions:	Drug: Esomeprazole Drug: Rabeprazole

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Rabeprazole 20 mg/Day	Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
Esomeprazole 40 mg/Day	Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
Esomeprazole 20 mg/Day	Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily

Participant Flow: Overall Study

	Rabeprazole 20 mg/Day	Esomeprazole 40 mg/Day	Esomeprazole 20 mg/Day
STARTED	464	469	459
COMPLETED	395	406	400
NOT COMPLETED	69	63	59
Adverse Event	22	27	16
Lost to Follow-up	29	19	20
Patient discontinued and other reasons	17	17	23
Physician Decision	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Rabeprazole 20 mg/Day	Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
Esomeprazole 40 mg/Day	Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
Esomeprazole 20 mg/Day	Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily

Baseline Measures

	Rabeprazole 20 mg/Day	Esomeprazole 40 mg/Day	Esomeprazole 20 mg/Day	Total
Number of Participants [units: participants]	464	469	459	1392
Age [units: years] Mean ± Standard Deviation	45.8 ± 14.8	48 ± 14.7	46.2 ± 14.8	46.7 ± 14.8
Gender [units: participants]
Female	204	208	208	620
Male	260	261	251	772
Region of Enrollment [units: participants]
Australia	464	469	459	1392

Outcome Measures

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1. Primary:

The Number of Patients With Complete Resolution of Heartburn by Week 4 [ Time Frame: week 4 of treatment ]

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2. Primary:

The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4 [ Time Frame: 4 weeks ]

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3. Primary:

The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4 [ Time Frame: 4 weeks ]

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4. Primary:

The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4 [ Time Frame: 4 weeks ]

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5. Secondary:

The Median Time to Complete Resolution of Heartburn Symptoms. [ Time Frame: week 4 of treatment ]

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6. Secondary:

The Median Time to Complete Relief of Regurgitation Symptoms [ Time Frame: 4 weeks ]

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7. Secondary:

The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods [ Time Frame: 4 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Executive Director, Medical & Scientific Affairs
Organization: Janssen-Cilag Pty Ltd
phone: +61 2 9815 3219
e-mail: mhandel@its.jnj.com

No publications provided by Janssen-Cilag Pty Ltd

Publications automatically indexed to this study:

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. Epub 2011 Feb 11.

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.

Responsible Party:	Executive Director, Medical and Scientific Affairs, Janssen-Cilag Pty Ltd, Australia
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:	August 26, 2010
Health Authority:	Australia: Department of Health