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Completed

NCT Number: NCT00734097

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)

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

esomeprazole 40 mg

Drug

Once a day

Other names: Nexium

Physical Exam

Procedure

every visit

Quality of life questionnaires

Other

every visit

pregnancy test, if applicable

Procedure

as needed

Primary outcomes

  1. Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment

    Time frame: At Baseline and 8 weeks

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

Secondary outcomes

  1. Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment

    Time frame: At Baseline and 4 weeks

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

  2. Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment

    Time frame: 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).

  3. Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment

    Time frame: 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).

  4. Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.

    Time frame: 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).

  5. Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.

    Time frame: 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).

  6. Change in Frequency of Epigastric Pain After 4 Weeks of Treatment

    Time frame: 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).

  7. Change in Frequency of Epigastric Pain After 8 Weeks of Treatment

    Time frame: 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).

  8. Change in Severity of Epigastric Pain After 8 Weeks of Treatment

    Time frame: 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).

  9. Change in Severity of Epigastric Pain After 4 Weeks of Treatment

    Time frame: 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).

  10. Change in Severity of Acid Regurgitation After 8 Weeks of Treatment

    Time frame: 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).

  11. Change in Severity of Acid Regurgitation After 4 Weeks of Treatment

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: NEON

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2008
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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