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CompletedNCT00272701Updated Mar 6, 2009

Esomeprazole in PPI Failures - IMPROVE

A Phase 4 interventional study of Esomeprazole and Other PPI marketed in Sweden in Gastroesophageal Reflux Disease, sponsored by AstraZeneca. Completed at 42 sites in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-03-06.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Gastroesophageal Reflux Disease
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's planned enrollment of 450 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
450 participants (estimated)

Interventions

  • DrugEsomeprazole
  • DrugOther PPI marketed in Sweden
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What researchers measure

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

07

Study locations

42 sites
  • Research Site
    Akersberga, Sweden
  • Research Site
    Arlov, Sweden
  • Research site
    Balsta, Sweden
  • Research Site
    Boras, Sweden
  • Research Site
    Bromma, Sweden
  • Research Site
    Bromolla, Sweden
  • Research Site
    Dalby, Sweden
  • Research Site
    Djursholm, Sweden
  • Research Site
    Enskededalen, Sweden
  • Research Site
    Goteborg, Sweden
  • Research Site
    Grangesberg, Sweden
  • Research Site
    Harnosand, Sweden
  • Research Site
    Helsingborg, Sweden
  • Research Site
    Hollviken, Sweden
  • Research Site
    Jarfalla, Sweden
  • Research Site
    Kil, Sweden
  • Research Site
    Knäred, Sweden
  • Research Site
    Koping, Sweden
  • Research Site
    Kristinehamn, Sweden
  • Research Site
    Linkoping, Sweden
  • Research Site
    Ludvika, Sweden
  • Research Site
    Lulea, Sweden
  • Research Site
    Lund, Sweden
  • Research Site
    Malmo, Sweden
  • Research Site
    Marsta, Sweden
  • Research Site
    Nacka, Sweden
  • Research Site
    Nykoping, Sweden
  • Research Site
    Orebro, Sweden
  • Research Site
    Partille, Sweden
  • Research Site
    Pitea, Sweden
  • Research Site
    Sandviken, Sweden
  • Research Site
    Solna, Sweden
  • Research Site
    Stenstorp, Sweden
  • Research Site
    Stockholm, Sweden
  • Research Site
    Sunne, Sweden
  • Research Site
    Trollhättan, Sweden
  • Research Site
    Täby, Sweden
  • Research Site
    Uppsala, Sweden
  • Research Site
    Vannas, Sweden
  • Research Site
    Varberg, Sweden
  • Research Site
    Varekil, Sweden
  • Research Site
    Vasteras, Sweden
08

References and documents

Publications

  • Ekesbo R, Sjostedt S, Sorngard H. Effects of structured follow-up and of more effective acid inhibitory treatment in the management of GORD patients in a Swedish primary-care setting: a randomized, open-label study. Clin Drug Investig. 2011;31(3):181-9. doi: 10.2165/11586330-000000000-00000. PubMed 21288053 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00272701
Lead sponsor
AstraZeneca
First posted
Jan 9, 2006
Start date
Dec 2005
Completion
Feb 2007
Last update
Mar 6, 2009

Study contacts

AstraZeneca Sweden Medical Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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