Gastroesophageal Reflux DiseasePhase 4NCT00272701
Esomeprazole in PPI Failures - IMPROVE
A Phase 4 study testing Esomeprazole and Other PPI marketed in Sweden in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 42 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Esomeprazole and Other PPI marketed in Sweden
- How many people
- 450 participants
- Where
- 42 sitesSweden
- Study dates
- Dec 2005to Feb 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
Sweden42 sites
Research Site
Åkersberga
Research Site
Arlöv
Research site
Bålsta
Research Site
Borås
Research Site
Bromma
Research Site
Bromölla
Research Site
Dalby
Research Site
Djursholm
Research Site
Enskededalen
Research Site
Gothenburg
Research Site
Grängesberg
Research Site
Härnösand
Research Site
Helsingborg
Research Site
Höllviken
Research Site
Jarfalla
Research Site
Kil
Research Site
Knäred
Research Site
Köping
Research Site
Kristinehamn
Research Site
Linköping
Research Site
Ludvika
Research Site
Luleå
Research Site
Lund
Research Site
Malmö
Research Site
Märsta
Research Site
Nacka
Research Site
Nyköping
Research Site
Örebro
Research Site
Partille
Research Site
Piteå
Research Site
Sandviken
Research Site
Solna
Research Site
Stenstorp
Research Site
Stockholm
Research Site
Sunne
Research Site
Täby
Research Site
Trollhättan
Research Site
Uppsala
Research Site
Vännäs
Research Site
Varberg
Research Site
Varekil
Research Site
Västerås
About this study
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.
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.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Esomeprazole, Other PPI marketed in Sweden
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Other PPI marketed in SwedenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients free from heartburn
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startDec 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Sweden Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272701
- Sponsor's protocol ID
- D9612L00085
- Other IDs
- IMPROVE, EudraCT-number 2005-000458-57
- Status last verified
- Aug 2007
- First submitted
- 4 Jan 2006
- Last updated
- 6 Mar 2009
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00272701
- Acronym / sponsor ID
- D9612L00085
- Conditions
- Gastroesophageal Reflux Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole | Drug | – |
| Other PPI marketed in Sweden | Drug | – |
Primary outcome
The proportion of patients free from heartburn
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
- Derived from this study: PubMed 21288053Ekesbo 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.
Related trials for Gastroesophageal Reflux Disease
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Sweden Medical Director, MD study director
AstraZeneca
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole and Other PPI marketed in Sweden in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 42 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients free from heartburn. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00272701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2009.