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

• ClinicalTrials.gov Identifier: NCT01249651
• Recruitment Status: Completed
• First Posted: November 30, 2010
• Results First Posted: October 31, 2012
• Last Update Posted: October 31, 2012
• Sponsor: AstraZeneca
• Collaborator: Quintiles, Inc.
• Information provided by (Responsible Party): AstraZeneca

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 (Clinical Trial)
• 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: November 2010
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: June 2011

Arms and Interventions

Arm	Intervention/treatment
1; One arm: esomeprazole 40 mg	Drug: esomeprazole 40 mg; esomeprazole 40 mg once daily, 8 weeks; Other Name: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

China

Research Site

Bejing, China

Sponsors and Collaborators

AstraZeneca

Quintiles, Inc.

Investigators

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

More Information

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01249651
• Other Study ID Numbers: D961HL00001
• First Posted: November 30, 2010
• Results First Posted: October 31, 2012
• Last Update Posted: October 31, 2012
• Last Verified: June 2012

Keywords provided by AstraZeneca:

Patients, Single

Additional relevant MeSH terms:

Heartburn; Signs and Symptoms, Digestive; Esomeprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action