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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
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: Esomeprazole 40 mg
Procedure: Physical Exam
Other: Quality of Life Questionnaires
Procedure: pregnancy test, if applicable
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).



Enrollment: 314
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nexium 40 mgs 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734097

Locations
Argentina
Research Site
Buenos Aires, Argentina
Chile
Research Site
Santiago de Chile, Chile
Research Site
Temuco, Chile
Research Site
Vina del Mar, Chile
Colombia
Research Site
Barranquilla, Colombia
Research Site
Bogota, Colombia
Research Site
Medellin, Colombia
Venezuela
Research Site
Barquisimeto, Venezuela
Research Site
Caracas, Venezuela
Research Site
San Cristobal, Venezuela
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00734097     History of Changes
Other Study ID Numbers: D9612L00116, NEON
Study First Received: August 11, 2008
Results First Received: September 25, 2009
Last Updated: September 10, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Venezuela: Ministerio de Salud y Desarrollo Social

Keywords provided by AstraZeneca:
heartburn
reflux
proton
pump
inhibitor

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014