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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: 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.


Original Primary Outcome: Assess the efficacy of esomeprazole 40 mg [ Time Frame: During the 7-day period prior to the 8 week visit (Visit 3) ]

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.


Current Secondary Outcome:

  • 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.
  • 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".
  • 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".


Original Secondary Outcome:

  • Change in the frequency of heartburn [ Time Frame: During the 7-day period prior to the 4 week visit (Visit 2) ]
    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) ]
    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 ]
    To assess the safety and tolerability of esomeprazole 40 mg by evaluating of adverse events (AEs) and vital signs (blood pressure and pulse rate).


Information By: AstraZeneca

Dates:
Date Received: November 26, 2010
Date Started: November 2010
Date Completion:
Last Updated: October 1, 2012
Last Verified: June 2012