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)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00734097

First received: August 11, 2008

Last updated: September 10, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 11, 2008
Last Updated Date	September 10, 2012
Start Date ^ICMJE	November 2007
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 10, 2012)	Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment [ Time Frame: At Baseline and 8 weeks ] [ Designated as safety issue: No ] Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline
Original Primary Outcome Measures ^ICMJE (submitted: August 12, 2008)	The primary objective of this study is to asses the change in the frequency of heartburn from entry to the end of the study, after 8-weeks treatment with Esomeprazole 40 mg compared to previous full dose PPI treatment given once daily. [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00734097 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 10, 2012)	Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment [ Time Frame: At Baseline and 4 weeks ] [ Designated as safety issue: No ] Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline. Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment [ Time Frame: At Baseline and 8 weeks ] [ Designated as safety issue: No ] 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 [ Time Frame: At Baseline and 4 weeks ] [ Designated as safety issue: Yes ] 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. [ Time Frame: At Baseline and 4 weeks. ] [ Designated as safety issue: No ] 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. [ Time Frame: At Baseline and 8 weeks. ] [ Designated as safety issue: No ] 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 [ Time Frame: At Baseline and 4 weeks ] [ Designated as safety issue: No ] 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 8 Weeks of Treatment [ Time Frame: At Baseline and 8 weeks ] [ Designated as safety issue: No ] 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 Severity of Epigastric Pain After 8 Weeks of Treatment [ Time Frame: At Baseline and 8 weeks ] [ Designated as safety issue: No ] 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 [ Time Frame: At Baseline and 4 weeks ] [ Designated as safety issue: No ] 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 [ Time Frame: At Baseline and 8 weeks ] [ Designated as safety issue: No ] 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 [ Time Frame: At Baseline and 4 weeks ] [ Designated as safety issue: No ] 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).
Original Secondary Outcome Measures ^ICMJE (submitted: August 12, 2008)	Change in: · 1) frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry· 2) symptom control from baseline to 4 and 8 weeks using QoL questionnaires [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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)
Official Title ^ICMJE	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)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Gastroesophageal Reflux Disease
Intervention ^ICMJE	Drug: Esomeprazole 40 mg Once a day Other Name: Nexium Procedure: Physical Exam every visit Other: Quality of Life Questionnaires every visit Procedure: pregnancy test, if applicable as needed
Study Arm (s)	Experimental: Nexium 40 mgs Interventions: Drug: Esomeprazole 40 mg Procedure: Physical Exam Other: Quality of Life Questionnaires Procedure: pregnancy test, if applicable
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	314
Completion Date	October 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Argentina, Chile, Colombia, Venezuela

Administrative Information
NCT Number ^ICMJE	NCT00734097
Other Study ID Numbers ^ICMJE	D9612L00116, NEON
Has Data Monitoring Committee	No
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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