Esomeprazole in PPI Failures - IMPROVE

Gastroesophageal Reflux Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272701
• Other study ID #: D9612L00085
• Secondary ID: IMPROVEEudraCT-n
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2006
• Last updated: March 5, 2009
• Start date: December 2005
• Est. completion date: February 2007

Study information

• Verified date: August 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Esomeprazole

• Other PPI marketed in Sweden

Locations

Country	Name	City	State
Sweden	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	Täby
Sweden	Research Site	Trollhättan
Sweden	Research Site	Uppsala
Sweden	Research Site	Vannas
Sweden	Research Site	Varberg
Sweden	Research Site	Varekil
Sweden	Research Site	Vasteras

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients free from heartburn
Secondary	Work Productivity and Activity Impairment Questionnaire: Gastro-Esophageal Reflux Disease questionnaire.
Secondary	EuroQol 5D questionnaire.
Secondary	Quality Assurance of GERD Treatment Questionnaire
Secondary	Willingness to pay
Secondary	Serious Adverse Events and Discontinuations due to Adverse Events