To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01249651
• Collaborator: Quintiles, Inc. (Industry)
• Enrollment: 101
• Location: 1
• Arm: 1
• Duration (Months): 7
• Patients Per Site Per Month: 14.5

Study Details

Study Description

Brief Summary

Administration of esomeprazole 40 mg to subjects who still had heartburn after receiving rabeprazole 20 mg once daily for 4 to 8 weeks will result in statistically significant improvement of heartburn after 8-week treatment.

Condition or Disease	Intervention/Treatment	Phase
Heartburn	Drug: esomeprazole 40 mg	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An 8-week, Open Label, Multicentre Study to Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects With Continuing Symptoms of Heartburn Following Treatment With a Previous Rabeprazole.
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 One arm: esomeprazole 40 mg	Drug: esomeprazole 40 mg; esomeprazole 40 mg once daily, 8 weeks; Other Names: No comparator

Outcome Measures

Primary Outcome Measures

1. Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1) [Baseline to 8 weeks]

   The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.

Secondary Outcome Measures

1. Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1) [Baseline and 4 weeks]

   The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.

2. Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1) [Baseline and 4 weeks]

   Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".

3. Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1) [Baseline to 8 weeks]

   Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female aged 20 years or more

• Documented history of reflux esophagitis verified by endoscopy in the past, including the grade of Los Angeles (LA) classification (Lundell LR et al 1999) before treatment

• Ongoing (until date of Visit 1) treatment with rabeprazole 20 mg, given once daily, for a period of 4 to 8 weeks. The subject must take Rabeprazole at least 4 days a week in the past 7 days prior to Visit 1.

• Persisting symptoms of heartburn during the past 7 days prior to Visit 1, judged by the investigator(s) as follows: At least 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities) OR At least 4 days with symptoms including mild ones (i.e. awareness of sign or symptom, but easily tolerated).

• The subject needs to be able to understand and read the official languages of the country.

Exclusion Criteria:

• Use of other PPIs and/or H2RA during rabeprazole treatment

• Previous use of esomeprazole 40 mg during the 12 weeks before enrolment

• Current or historical evidence of gastrointestinal pathology

• History, signs or symptoms of clinically significant or uncontrolled cardiovascular, pulmonary, renal, endocrine, hematologic, neurologic, psychiatric pancreatic or hepatic disease as judged by the investigator to interfere with the conduct of the study, the interpretation of study results, subject compliance, or the health of the subject during the study.

• Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or pyloroplasty, hiatus hernia surgery or fundoplication. Note: endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection or simple suturing of an ulcer are not exclusion criteria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Bejing		China

Sponsors and Collaborators

• AstraZeneca
• Quintiles, Inc.

Investigators

• Study Director: Masataka Date, MD, PhD, AstraZeneca KK Corporate Communications

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01249651
• Other Study ID Numbers: D961HL00001
• First Posted: Nov 30, 2010
• Last Update Posted: Oct 31, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by AstraZeneca: Patients, Single
• Additional relevant MeSH terms: Heartburn; Esomeprazole

Study Results

Participant Flow

Recruitment Details	First participant enrolled on 23 November 2010. Last participant completed on 11 June 2011. Out of 101 enrolled participants, 100 participants (target was 100) received esomeprazole 40 mg. All of the participants were included in safety analysis set and 96 out of the 100 participants were included in the full analysis set for efficacy analyses.
Pre-assignment Detail	Participants with a history of reflux oesophagitis and with continuing heartburn after previous treatment with rabeprazole 20 mg were included in this study.

Arm/Group Title	Esomeprazole 40 mg
Arm/Group Description	esomeprazole 40 mg once daily, 8 weeks
Period Title: Overall Study
STARTED	101
COMPLETED	94
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Esomeprazole 40 mg
Arm/Group Description	esomeprazole 40 mg once daily, 8 weeks
Overall Participants	101
Age (Year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Year]	51.2 (13.71)
Sex: Female, Male (Count of Participants)
Female	41 40.6%
Male	60 59.4%

Outcome Measures

1. Primary Outcome

Title	Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)
Description	The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Full analysis set (96 participants)

Arm/Group Title	Arm 1 - Esomeprazole 40 mg
Arm/Group Description	esomeprazole 40 mg once daily, 8 weeks
Measure Participants	96
Mean (Standard Deviation) [Number of days]	-3.3 (2.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1 - Esomeprazole 40 mg
	Comments	Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilocoxon signed-rank test
	Comments

2. Secondary Outcome

Title	Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)
Description	The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

92 Participants in the Full analysis set (96 participants) had data of heartburn.

Arm/Group Title	Arm 1 - Esomeprazole 40 mg
Arm/Group Description	esomeprazole 40 mg once daily, 8 weeks
Measure Participants	92
Mean (Standard Deviation) [Number of days]	-2.6 (2.82)

3. Secondary Outcome

Title	Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)
Description	Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

92 Participants in the Full analysis set (96 participants) had data of heartburn at week 4.

Arm/Group Title	Arm 1 - Esomeprazole 40 mg
Arm/Group Description	esomeprazole 40 mg once daily, 8 weeks
Measure Participants	92
Improved	77 76.2%
Unchanged	14 13.9%
Worsened	1 1%

4. Secondary Outcome

Title	Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)
Description	Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Full analysis set (96 participants)

Arm/Group Title	Arm 1 - Esomeprazole 40 mg
Arm/Group Description	esomeprazole 40 mg once daily, 8 weeks
Measure Participants	96
Improved	83 82.2%
Unchanged	12 11.9%
Worsened	1 1%

Adverse Events

Arm/Group Title	Esomeprazole 40 mg
Arm/Group Description	esomeprazole 40 mg once daily, 8 weeks
All Cause Mortality
	Esomeprazole 40 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Esomeprazole 40 mg
	Affected / at Risk (%)	# Events
Total	0/100 (0%)
Other (Not Including Serious) Adverse Events
	Esomeprazole 40 mg
	Affected / at Risk (%)	# Events
Total	2/100 (2%)
Infections and infestations
Nasopharyngitis	2/100 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.