Clinical trial NCT00272701: Esomeprazole in PPI Failures - IMPROVE
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The proportion of patients free from heartburn
Secondary outcomes:
measure: Work Productivity and Activity Impairment Questionnaire: Gastro-Esophageal Reflux Disease questionnaire.
measure: EuroQol 5D questionnaire.
measure: Quality Assurance of GERD Treatment Questionnaire
measure: Willingness to pay
measure: Serious Adverse Events and Discontinuations due to Adverse Events
Other outcomes:
Locations:
city: Akersberga
country: Sweden
facility: Research Site
city: Arlov
country: Sweden
facility: Research Site
city: Balsta
country: Sweden
facility: Research site
city: Boras
country: Sweden
facility: Research Site
city: Bromma
country: Sweden
facility: Research Site
city: Bromolla
country: Sweden
facility: Research Site
city: Dalby
country: Sweden
facility: Research Site
city: Djursholm
country: Sweden
facility: Research Site
city: Enskededalen
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Grangesberg
country: Sweden
facility: Research Site
city: Harnosand
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Hollviken
country: Sweden
facility: Research Site
city: Jarfalla
country: Sweden
facility: Research Site
city: Kil
country: Sweden
facility: Research Site
city: Knäred
country: Sweden
facility: Research Site
city: Koping
country: Sweden
facility: Research Site
city: Kristinehamn
country: Sweden
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Ludvika
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Marsta
country: Sweden
facility: Research Site
city: Nacka
country: Sweden
facility: Research Site
city: Nykoping
country: Sweden
facility: Research Site
city: Orebro
country: Sweden
facility: Research Site
city: Partille
country: Sweden
facility: Research Site
city: Pitea
country: Sweden
facility: Research Site
city: Sandviken
country: Sweden
facility: Research Site
city: Solna
country: Sweden
facility: Research Site
city: Stenstorp
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Sunne
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Täby
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Vannas
country: Sweden
facility: Research Site
city: Varberg
country: Sweden
facility: Research Site
city: Varekil
country: Sweden
facility: Research Site
city: Vasteras
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Sweden Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.