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CompletedNCT01249651Updated Oct 31, 2012Results posted

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

A Phase 4 interventional study of esomeprazole 40 mg in Heartburn, sponsored by AstraZeneca. Completed at 1 site in China. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-10-31.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
101
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heartburn

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Keywords

  • Patients, Single
03

In context

Heartburn

104 studies on the registry are indexed under Heartburn; 9 are open to participants now.

This study's enrollment of 101 is close to the median of 100 across 85 interventional studies indexed under Heartburn.

Browse Heartburn studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • Other
    1

    One arm: esomeprazole 40 mg

    Drug: esomeprazole 40 mg

Interventions

06

What researchers measure

Primary outcomes

  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)

    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.

    Time frame: Baseline to 8 weeks

Secondary outcomes

  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)

    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.

    Time frame: Baseline and 4 weeks

  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)

    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".

    Time frame: Baseline and 4 weeks

  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)

    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".

    Time frame: Baseline to 8 weeks

07

Results

Posted Oct 31, 2012

Participant flow

First participant enrolled on 23 November 2010. Last participant completed on 11 June 2011. Out of 101 enrolled participants, 100 participants (target was 100) received esomeprazole 40 mg. All of the participants were included in safety analysis set and 96 out of the 100 participants were included in the full analysis set for efficacy analyses.

Participant flow — Overall Study
MilestoneEsomeprazole 40 mg
Started101
Completed94
Not completed7
Withdrew: Withdrawal by subject4
Withdrew: Adverse event1
Withdrew: Protocol violation1
Withdrew: Sponsor decision1

Outcome measures

PrimaryChange 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)

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.

Time frame:
Baseline to 8 weeks
Reported as:
Mean · Number of days
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)
Number of daysArm 1 - Esomeprazole 40 mg
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)-3.3 ± 2.36
Statistical analysis
  • Arm 1 - Esomeprazole 40 mg · Wilocoxon signed-rank test · p = <0.001
SecondaryChange 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)

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.

Time frame:
Baseline and 4 weeks
Reported as:
Mean · Number of days
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)
Number of daysArm 1 - Esomeprazole 40 mg
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)-2.6 ± 2.82
SecondaryChange 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)

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".

Time frame:
Baseline and 4 weeks
Reported as:
Number · Participants
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)
ParticipantsArm 1 - Esomeprazole 40 mg
Improved77
Unchanged14
Worsened1
SecondaryChange 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)

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".

Time frame:
Baseline to 8 weeks
Reported as:
Number · Participants
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)
ParticipantsArm 1 - Esomeprazole 40 mg
Improved83
Unchanged12
Worsened1

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Esomeprazole 40 mg—0/100 (0%)2/100 (2%)
Most frequent other events
Most frequent other events
EventEsomeprazole 40 mg
NasopharyngitisInfections and infestations2/100

Baseline characteristics

Age Continuous
Age Continuous(Year)Esomeprazole 40 mg
Mean51.2 ± 13.71
Sex: Female, Male
Sex: Female, Male(Participants)Esomeprazole 40 mg
Female41
Male60
08

Study locations

1 site
  • Research Site
    Beijing, China
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2010, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

Results were first posted in Oct 2012, 1 year 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2010
First posted
Nov 30, 2010
Start
Nov 2010
Primary completionActual
Jun 2011
CompletionActual
Jun 2011
Results first posted
Oct 31, 2012
Last update
Oct 31, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01249651
Lead sponsor
AstraZeneca
Collaborators
Quintiles, Inc.
Responsible party
Sponsor
First posted
Nov 30, 2010
Start date
Nov 2010
Primary completion
Jun 2011
Completion
Jun 2011
Results posted
Oct 31, 2012
Last update
Oct 31, 2012

Study contacts

Masataka Date, MD, PhD
study director · AstraZeneca KK Corporate Communications
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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