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OpenTrials
Completed

NCT Number: NCT00272701

Esomeprazole in PPI Failures - IMPROVE

The purpose of this study is to assess how PPI treated GERD patients with insufficient symptom control will benefit from a change in management by providing a more efficient acid secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to pre-study PPI treatment.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Arlöv, Sweden

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of informed consent
  • Male or female, aged 18-65 years
  • History of GERD symptoms during, at least, six months prior to enrolment
  • PPI as maintenance treatment during the last 30 days prior to enrolment
  • Heartburn as predominant GERD symptom, as judged by the investigator
  • Persisting GERD symptoms during the past 7 days prior to visit 1, judged by the patient as either: 4 days with mild symptoms (i.e. awareness of sign or symptom, but easily tolerated)or 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities)

Exclusion criteria

  • Any treatment with esomeprazole during 30 days prior to enrolment History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer
  • Current or historical evidence of the following diseases/conditions, as judged by the investigator:Zollinger-Ellison syndrome,Primary esophageal motility disorder, i.e. achalasia, scleroderma, primary esophageal spasm,
  • Gastric or duodenal ulcers within the last three months, Malabsorbtion
  • Malignancy or other concomitant disease with poor prognosis or which may interfere with the assessments in the study
  • Unstable diabetes mellitus. Stable diabetes controlled by diet, oral agents or insulin is acceptable
  • Patients with severe diseases or disorders which may interfere with the conduct of the study

Treatment and study plan

Esomeprazole

Drug

Other PPI marketed in Sweden

Drug

Primary outcomes

  1. The proportion of patients free from heartburn

Secondary outcomes

  1. Work Productivity and Activity Impairment Questionnaire: Gastro-Esophageal Reflux Disease questionnaire.

  2. EuroQol 5D questionnaire.

  3. Quality Assurance of GERD Treatment Questionnaire

  4. Willingness to pay

  5. Serious Adverse Events and Discontinuations due to Adverse Events

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Open, Phase IV, Parallel Group Multicentre Study to Evaluate a Change of Management in Gastroesophageal Reflux Disease (GERD) Patients by Treatment With Esomeprazole 40 mg or Any Other Proton Pump Inhibitor (PPI), After Initial Treatment Failure, in Ordinary Clinical Practice During 4 Weeks.

Important dates

Study start
2005
Study completion
2007
First posted
Jan 9, 2006
Registry last updated
Mar 6, 2009

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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