Trial Outcomes & Findings for To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole (NCT NCT01249651)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

101 participants

Primary outcome timeframe

Baseline to 8 weeks

Results posted on

2012-10-31

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.

Participants with a history of reflux oesophagitis and with continuing heartburn after previous treatment with rabeprazole 20 mg were included in this study.

Participant milestones

Participant milestones
Measure	Esomeprazole 40 mg esomeprazole 40 mg once daily, 8 weeks
Overall Study STARTED	101
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Esomeprazole 40 mg esomeprazole 40 mg once daily, 8 weeks
Overall Study Withdrawal by Subject	4
Overall Study Adverse Event	1
Overall Study Protocol Violation	1
Overall Study Sponsor Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esomeprazole 40 mg n=101 Participants esomeprazole 40 mg once daily, 8 weeks
Age Continuous	51.2 Year STANDARD_DEVIATION 13.71 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: Full analysis set (96 participants)

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.

Outcome measures

Outcome measures
Measure	Arm 1 - Esomeprazole 40 mg n=96 Participants esomeprazole 40 mg once daily, 8 weeks
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 Number of days Standard Deviation 2.36

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: 92 Participants in the Full analysis set (96 participants) had data of heartburn.

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.

Outcome measures

Outcome measures
Measure	Arm 1 - Esomeprazole 40 mg n=92 Participants esomeprazole 40 mg once daily, 8 weeks
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 Number of days Standard Deviation 2.82

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: 92 Participants in the Full analysis set (96 participants) had data of heartburn at week 4.

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".

Outcome measures

Outcome measures
Measure	Arm 1 - Esomeprazole 40 mg n=92 Participants esomeprazole 40 mg once daily, 8 weeks
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) Improved	77 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) Unchanged	14 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) Worsened	1 Participants

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Full analysis set (96 participants)

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".

Outcome measures

Outcome measures
Measure	Arm 1 - Esomeprazole 40 mg n=96 Participants esomeprazole 40 mg once daily, 8 weeks
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) Improved	83 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) Unchanged	12 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) Worsened	1 Participants

Adverse Events

Esomeprazole 40 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Esomeprazole 40 mg n=100 participants at risk esomeprazole 40 mg once daily, 8 weeks
Infections and infestations Nasopharyngitis	2.0% 2/100

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.
Publication restrictions are in place

Restriction type: OTHER