Clinical trial NCT01249651: To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heartburn
Keywords: Patients, Single
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2010-11-30
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: 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)
timeFrame: Baseline and 4 weeks
measure: 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)
timeFrame: Baseline and 4 weeks
measure: 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)
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Bejing
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca KK Corporate Communications
name: Masataka Date, MD, PhD
role: STUDY_DIRECTOR
References: