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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

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)

Research Site

An open label, multicentre 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)

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

Age Continuous

Gender, Male/Female

Change in Frequency of days with Heartburn from baseline to 8 weeks of treatment

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

Change in Frequency of days with Heartburn from baseline to 4 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).

Change in Severity of  Heartburn from baseline to 8 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).

Change in Severity of Heartburn 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).

Change in Frequency of days with Acid Regurgitation from baseline to 4 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).

Change in Frequency of days with Acid Regurgitation from baseline to 8 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).

Change in Frequency of Epigastric Pain after 4 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).

Change in Frequency 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).

Change in Severity of Epigastric Pain after 8 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).

Change in Severity of Epigastric Pain after 4 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).

Change in Severity of Acid Regurgitation after 8 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).

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) - NEON

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=436&filename=CSR-D9612L00116.pdf

CSR-D9612L00116.pdf

Trial Results Summaries

Contacts

Contact