Esomeprazole in PPI Failures - IMPROVE

NCT ID: NCT00272701

Last Updated: 2009-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Esomeprazole

Intervention Type DRUG

Other PPI marketed in Sweden

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Sweden Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Arlöv, , Sweden

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Åkersberga, , Sweden

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Bålsta, , Sweden

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Borås, , Sweden

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Bromma, , Sweden

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Bromölla, , Sweden

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Dalby, , Sweden

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Djursholm, , Sweden

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Enskededalen, , Sweden

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Gothenburg, , Sweden

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Grängesberg, , Sweden

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Härnösand, , Sweden

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Helsingborg, , Sweden

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Höllviken, , Sweden

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Jarfalla, , Sweden

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Kil, , Sweden

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Knäred, , Sweden

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Köping, , Sweden

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Kristinehamn, , Sweden

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Linköping, , Sweden

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Ludvika, , Sweden

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Luleå, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Märsta, , Sweden

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Nacka, , Sweden

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Nyköping, , Sweden

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Örebro, , Sweden

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Partille, , Sweden

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Piteå, , Sweden

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Sandviken, , Sweden

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Solna, , Sweden

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Stenstorp, , Sweden

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Stockholm, , Sweden

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Sunne, , Sweden

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Täby, , Sweden

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Trollhättan, , Sweden

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Uppsala, , Sweden

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Varberg, , Sweden

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Varekil, , Sweden

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Vännäs, , Sweden

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Västerås, , Sweden

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Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 21288053 (View on PubMed)

Other Identifiers

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IMPROVE

Identifier Type: -

Identifier Source: secondary_id

EudraCT-number 2005-000458-57

Identifier Type: -

Identifier Source: secondary_id

D9612L00085

Identifier Type: -

Identifier Source: org_study_id

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