Esomeprazole in PPI Failures - IMPROVE
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00272701
First received: January 4, 2006
Last updated: March 5, 2009
Last verified: August 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease |
Drug: Esomeprazole Drug: Other PPI marketed in Sweden |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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. |
Resource links provided by NLM:
MedlinePlus related topics:
GERD
Drug Information available for:
Omeprazole
Omeprazole magnesium
Esomeprazole
Esomeprazole Sodium
Esomeprazole magnesium
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- The proportion of patients free from heartburn
Secondary Outcome Measures:
- Work Productivity and Activity Impairment Questionnaire: Gastro-Esophageal Reflux Disease questionnaire.
- EuroQol 5D questionnaire.
- Quality Assurance of GERD Treatment Questionnaire
- Willingness to pay
- Serious Adverse Events and Discontinuations due to Adverse Events
| Estimated Enrollment: | 450 |
| Study Start Date: | December 2005 |
| Study Completion Date: | February 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272701
Locations
| Sweden | |
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| Akersberga, Sweden | |
| Research Site | |
| Arlov, Sweden | |
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| Balsta, Sweden | |
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| Boras, Sweden | |
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| Bromma, Sweden | |
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| Bromolla, Sweden | |
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| Dalby, Sweden | |
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| Djursholm, Sweden | |
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| Enskededalen, Sweden | |
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| Goteborg, Sweden | |
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| Grangesberg, Sweden | |
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| Harnosand, Sweden | |
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| Helsingborg, Sweden | |
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| Hollviken, Sweden | |
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| Jarfalla, Sweden | |
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| Kil, Sweden | |
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| Knäred, Sweden | |
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| Koping, Sweden | |
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| Kristinehamn, Sweden | |
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| Linkoping, Sweden | |
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| Ludvika, Sweden | |
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| Lulea, Sweden | |
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| Lund, Sweden | |
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| Malmo, Sweden | |
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| Marsta, Sweden | |
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| Nacka, Sweden | |
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| Nykoping, Sweden | |
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| Orebro, Sweden | |
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| Partille, Sweden | |
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| Pitea, 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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| Trollhättan, Sweden | |
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| Täby, Sweden | |
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| Uppsala, Sweden | |
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| Vannas, Sweden | |
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| Varberg, Sweden | |
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| Varekil, Sweden | |
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| Vasteras, Sweden | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Sweden Medical Director, MD | AstraZeneca |
More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00272701 History of Changes |
| Other Study ID Numbers: | D9612L00085, IMPROVE, EudraCT-number 2005-000458-57 |
| Study First Received: | January 4, 2006 |
| Last Updated: | March 5, 2009 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Omeprazole |
Proton Pump Inhibitors Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013