Trial Outcomes & Findings for To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole (NCT NCT01397084)

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

107 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2013-02-21

Participant Flow

First participant enrolled on 25 August 2011. Last participant completed on 31 January 2012. Out of 108 enrolled participants, 107 participants (target was 100) received esomeprazole 20 mg. All of the participants were included in safety analysis set and 104 out of the 107 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 10 mg were included in this study.

Participant milestones

Participant milestones
Measure	Esomeprazole 20 mg esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
Overall Study STARTED	108
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Esomeprazole 20 mg esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
Overall Study Severe Non-Compliance to Protocol	1
Overall Study Protocol Violation	2
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1
Overall Study Used other proton pump inhibitor	1

Baseline Characteristics

To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esomeprazole 20 mg n=104 Participants esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
Age Continuous	50.9 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Efficacy Population (104 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	Esomeprazole 20 mg n=104 Participants esomeprazole 20 mg once daily for 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).	-3.0 Days with heartburn Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: 101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.

The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) 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	Esomeprazole 20 mg n=101 Participants esomeprazole 20 mg once daily for 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).	-2.4 Days with heartburn Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline and 4 weeks.

Population: 101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.

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	Esomeprazole 20 mg n=101 Participants esomeprazole 20 mg once daily for 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 Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). Improved	76 Participants
Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). Unchanged	24 Participants
Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). Worsened	1 Participants

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Efficacy Population (104 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	Esomeprazole 20 mg n=104 Participants esomeprazole 20 mg once daily for 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 Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). Improved	84 Participants
Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). Unchanged	18 Participants
Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). Worsened	2 Participants

Adverse Events

Esomeprazole 20 mg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Esomeprazole 20 mg n=107 participants at risk esomeprazole 20 mg once daily for 8 weeks
Infections and infestations Typhoid Fever	0.93% 1/107
Gastrointestinal disorders Inguinal hernia	0.93% 1/107

Other adverse events

Other adverse events
Measure	Esomeprazole 20 mg n=107 participants at risk esomeprazole 20 mg once daily for 8 weeks
Gastrointestinal disorders Diarrhoea	1.9% 2/107

Additional Information

James Armbrust

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