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

August 11, 2008
September 10, 2012
November 2007
October 2008   (final data collection date for primary outcome measure)
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
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 ]
Complete list of historical versions of study NCT00734097 on ClinicalTrials.gov Archive Site
  • 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).

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 ]
Not Provided
Not Provided
 
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)
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • 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
Experimental: Nexium 40 mgs
Interventions:
  • Drug: Esomeprazole 40 mg
  • Procedure: Physical Exam
  • Other: Quality of Life Questionnaires
  • Procedure: pregnancy test, if applicable
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
314
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Chile,   Colombia,   Venezuela
 
NCT00734097
D9612L00116, NEON
No
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP