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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

November 26, 2010
October 1, 2012
November 2010
June 2011   (final data collection date for primary outcome 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) [ 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.
Assess the efficacy of esomeprazole 40 mg [ Time Frame: During the 7-day period prior to the 8 week visit (Visit 3) ] [ Designated as safety issue: No ]
To assess the efficacy of esomeprazole 40 mg once daily in subjects who still had heartburn after receiving rabeprazole 20 mg once daily for 4 to 8 weeks by evaluating 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 Visit 1, after treatment with esomeprazole 40 mg.
Complete list of historical versions of study NCT01249651 on ClinicalTrials.gov Archive Site
  • 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".
  • Change in the frequency of heartburn [ Time Frame: During the 7-day period prior to the 4 week visit (Visit 2) ] [ Designated as safety issue: No ]
    To assess the efficacy of esomeprazole 40 mg by evaluating the 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 Visit 1.
  • Changes in the maximum severity of heartburn [ Time Frame: During the 7-day period prior to the 4 week visit (Visit 2) and the 8 week visit (Visit 3) ] [ Designated as safety issue: No ]
    To assess the efficacy of esomeprazole 40 mg by evaluating the changes in the maximum severity of heartburn during the 7-day period prior to the 4 week visit (Visit 2) and the 8 week visit (Visit 3) compared to the maximum severity of heartburn during the 7-day period prior to Visit 1.
  • Safety and tolerability of esomeprazole 40 mg [ Time Frame: Until last visit ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of esomeprazole 40 mg by evaluating of adverse events (AEs) and vital signs (blood pressure and pulse rate).
Not Provided
Not Provided
 
To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole
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.

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heartburn
Drug: esomeprazole 40 mg
esomeprazole 40 mg once daily, 8 weeks
Other Name: No comparator
1
One arm: esomeprazole 40 mg
Intervention: Drug: esomeprazole 40 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01249651
D961HL00001
Not Provided
AstraZeneca
AstraZeneca
Quintiles East Asia Pte. Ltd.
Study Director: Masataka Date, MD, PhD AstraZeneca KK Corporate Communications
AstraZeneca
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP