Gastroesophageal Reflux Disease
Conditions
Keywords
heartburn, reflux, proton, pump, inhibitor
Brief summary
The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.
Interventions
Once a day
PROCEDUREPhysical Exam
every visit
OTHERQuality of Life Questionnaires
every visit
PROCEDUREpregnancy test, if applicable
as needed
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor * informed consent * over 18 years of age
Exclusion criteria
* Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study * More than 1 other course of PPI treatment in the previous 12 month * previous use of esomeprazole * presence of alarm symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment | At Baseline and 8 weeks | Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment | 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). |
| Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment | 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). |
| Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment. | 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). |
| Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment. | 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). |
| Change in Frequency of Epigastric Pain After 4 Weeks of Treatment | 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). |
| Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment | At Baseline and 4 weeks | Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline. |
| Change in Severity of Epigastric Pain After 8 Weeks of Treatment | 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). |
| Change in Severity of Epigastric Pain After 4 Weeks of Treatment | 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). |
| Change in Severity of Acid Regurgitation After 8 Weeks of Treatment | 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). |
| Change in Severity of Acid Regurgitation After 4 Weeks of Treatment | 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). |
| Change in Frequency of Epigastric Pain After 8 Weeks of Treatment | 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). |
Countries
Argentina, Chile, Colombia, Venezuela
Participant flow
Recruitment details
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).
Pre-assignment details
All participants received 8-weeks open label esomeprazole treatment.
Participants by arm
| Arm | Count |
|---|---|
| Esomeprazole 40mg, Daily Open-label daily esomeprazole 40 mg, daily for 8 weeks | 311 |
| Total | 311 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Open Label | Lost to Follow-up | 7 |
| Open Label | Protocol Violation | 4 |
| Open Label | Withdrawal by Subject | 5 |
| Screening | Lost to Follow-up | 2 |
| Screening | Protocol Violation | 12 |
| Screening | Unconfirmed pregnancy | 1 |
| Screening | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Esomeprazole 40mg, Daily |
|---|---|
| Age Continuous | 42.7 Years STANDARD_DEVIATION 14.3 |
| Sex: Female, Male Female | 212 Participants |
| Sex: Female, Male Male | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 317 |
| serious Total, serious adverse events | 4 / 317 |
Outcome results
Primary
Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment
Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline
Time frame: At Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | 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
Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.
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).
Time frame: At Baseline and 4 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | 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
Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.
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).
Time frame: At Baseline and 8 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | 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
Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment
Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.
Time frame: At Baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | 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
Change in Frequency of Epigastric Pain After 4 Weeks of Treatment
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).
Time frame: At Baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | Change in Frequency of Epigastric Pain After 4 Weeks of Treatment | -2.77 Days per week with pain | Standard Deviation 2.5 |
Secondary
Change in Frequency of Epigastric Pain After 8 Weeks of Treatment
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).
Time frame: At Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | Change in Frequency of Epigastric Pain After 8 Weeks of Treatment | -3.16 Days per week with pain | Standard Deviation 2.52 |
Secondary
Change in Severity of Acid Regurgitation After 4 Weeks of Treatment
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).
Time frame: At Baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | Change in Severity of Acid Regurgitation After 4 Weeks of Treatment | -1.31 Units of scale | Standard Deviation 1.06 |
Secondary
Change in Severity of Acid Regurgitation After 8 Weeks of Treatment
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).
Time frame: At Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | Change in Severity of Acid Regurgitation After 8 Weeks of Treatment | -1.51 Units of scale | Standard Deviation 1.09 |
Secondary
Change in Severity of Epigastric Pain After 4 Weeks of Treatment
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).
Time frame: At Baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | Change in Severity of Epigastric Pain After 4 Weeks of Treatment | -1.17 Units of scale | Standard Deviation 1.1 |
Secondary
Change in Severity of Epigastric Pain After 8 Weeks of Treatment
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).
Time frame: At Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | Change in Severity of Epigastric Pain After 8 Weeks of Treatment | -1.34 Units of scale | Standard Deviation 1.1 |
Secondary
Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment
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).
Time frame: At Baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment | -1.34 Units on scale | Standard Deviation 1.03 |
Secondary
Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment
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).
Time frame: At Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 40mg, Daily | Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment | -1.56 Units of scale | Standard Deviation 1.01 |