Trial Outcomes & Findings for A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI) (NCT NCT00734097)

Results Overview

Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

314 participants

Primary outcome timeframe

At Baseline and 8 weeks

Results posted on

2012-10-10

Participant Flow

Participants with persisting symptoms of Gastroesophageal Reflux Disease (GORD) despite previous treatment with a full dose proton pump inhibitor were enrolled across the Argentina (6 sites), Chile (3 sites) Colombia (9 sites) and Venezuela (2 sites).

All participants received 8-weeks open label esomeprazole treatment.

Participant milestones

Participant milestones
Measure	Esomeprazole 40mg, Daily Open-label daily esomeprazole 40 mg, daily for 8 weeks
Screening STARTED	337
Screening COMPLETED	317
Screening NOT COMPLETED	20
Open Label STARTED	317
Open Label Safety Analysis	317
Open Label Full Analysis	311
Open Label Per Protocol	301
Open Label COMPLETED	301
Open Label NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Esomeprazole 40mg, Daily Open-label daily esomeprazole 40 mg, daily for 8 weeks
Screening Protocol Violation	12
Screening Withdrawal by Subject	5
Screening Lost to Follow-up	2
Screening Unconfirmed pregnancy	1
Open Label Lost to Follow-up	7
Open Label Withdrawal by Subject	5
Open Label Protocol Violation	4

Baseline Characteristics

A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Age Continuous	42.7 Years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	212 Participants n=5 Participants
Sex: Female, Male Male	99 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Baseline and 8 weeks

Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment	-3.44 Days per week with symptoms Standard Deviation 2.35

SECONDARY outcome

Timeframe: At Baseline and 4 weeks

Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment	-3.08 Days per week with symptoms Standard Deviation 2.32

SECONDARY outcome

Timeframe: At Baseline and 8 weeks

Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment	-1.56 Units of scale Standard Deviation 1.01

SECONDARY outcome

Timeframe: At Baseline and 4 weeks

Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment	-1.34 Units on scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: At Baseline and 4 weeks.

Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.	-2.95 Days per week with symptoms Standard Deviation 2.42

SECONDARY outcome

Timeframe: At Baseline and 8 weeks.

Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.	-3.28 Days per week with symptoms Standard Deviation 2.51

SECONDARY outcome

Timeframe: At Baseline and 4 weeks

Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Frequency of Epigastric Pain After 4 Weeks of Treatment	-2.77 Days per week with pain Standard Deviation 2.5

SECONDARY outcome

Timeframe: At Baseline and 8 weeks

Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline. Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe).

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Frequency of Epigastric Pain After 8 Weeks of Treatment	-3.16 Days per week with pain Standard Deviation 2.52

SECONDARY outcome

Timeframe: At Baseline and 8 weeks

Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Severity of Epigastric Pain After 8 Weeks of Treatment	-1.34 Units of scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: At Baseline and 4 weeks

Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Severity of Epigastric Pain After 4 Weeks of Treatment	-1.17 Units of scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: At Baseline and 8 weeks

Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Severity of Acid Regurgitation After 8 Weeks of Treatment	-1.51 Units of scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: At Baseline and 4 weeks

Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe". Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

Outcome measures

Outcome measures
Measure	Esomeprazole 40mg, Daily n=311 Participants Open-label daily esomeprazole 40 mg, daily for 8 weeks
Change in Severity of Acid Regurgitation After 4 Weeks of Treatment	-1.31 Units of scale Standard Deviation 1.06

Adverse Events

Esomeprazole 40mg, Daily

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Esomeprazole 40mg, Daily n=317 participants at risk Open-label daily esomeprazole 40 mg, daily for 8 weeks
Cardiac disorders Dizziness / Hypotension / Tachycardia	0.32% 1/317
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.32% 1/317
Reproductive system and breast disorders Vaginal haemorrhage	0.32% 1/317
Reproductive system and breast disorders Uterine Leiomyoma	0.32% 1/317

Other adverse events

Other adverse events
Measure	Esomeprazole 40mg, Daily n=317 participants at risk Open-label daily esomeprazole 40 mg, daily for 8 weeks
Nervous system disorders Headache	5.0% 16/317

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60