Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Quintiles East Asia Pte. Ltd.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01249651
First received: November 26, 2010
Last updated: October 1, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Heartburn
 Drug: esomeprazole 40 mg
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Heartburn
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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".

  • 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 ] [ Designated as safety issue: No ]
    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".


Enrollment: 101
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
One arm: esomeprazole 40 mg
 Drug: esomeprazole 40 mg
esomeprazole 40 mg once daily, 8 weeks
Other Name: No comparator

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249651

Locations
China
Research Site
Bejing, China
Sponsors and Collaborators
AstraZeneca
Quintiles East Asia Pte. Ltd.
Investigators
Study Director: Masataka Date, MD, PhD AstraZeneca KK Corporate Communications
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01249651     History of Changes
Other Study ID Numbers: D961HL00001
Study First Received: November 26, 2010
Results First Received: June 8, 2012
Last Updated: October 1, 2012
Health Authority: Korea: Food and Drug Administration
Taiwan : Food and Drug Administration
China: Food and Drug Administration

Keywords provided by AstraZeneca:
Patients, Single

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Omeprazole
Rabeprazole
Anti-Ulcer Agents
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013