Study of Long-Term Use of Proton-Pump-Inhibitors in Gener... | NCT00363701

Studies
Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice

NCT00363701

Sponsor

Glostrup University Hospital, Copenhagen

Status

Unknown status

Last Update Posted

Aug 15, 2006Estimated

Enrollment

150

Phase

Phase 4

Conditions

Dyspepsia
Gastroesophageal Refluxdisease
Ulcer

Interventions

esomeprazole

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Not provided

Completion Date

Feb 2008

First Submitted Date

Aug 14, 2006

First Submission Date that Met QC Criteria

Aug 14, 2006

First Posted Date

Aug 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2006

Last Update Posted Date

Aug 15, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Not provided

Description Module

Brief Summary

The primary purpose of the study is to determine the effect of esomeprazole compared to placebo in patients from general practice who have previously been treated with proton-pump-inhibitors (PPI) and who have no upper endoscopic findings.

Detailed Description

The majority of patients with dyspepsia are treated in primary care with acid-suppressive therapy for shorter or longer periods of time on the assumption that the patients´ symptoms are related to the production of acid in the stomach.

In about half of the dyspeptic patients there is no structural or biochemical explanation for their symptoms. These patients suffer from functional dyspepsia.

Treatment with proton-pump-inhibitors is effective in treating patients with gastroesophageal refluxdisease or ulcers. It is however controversial if acid-suppressive treatment is effective in the large group of patients with functional dyspepsia. Previous studies have shown no or very modest effect with a very high placeboresponse rate of 40-50%.

In primary care patients with upper abdominal symptoms are often treated with PPI as a diagnostic tool. If the treatment is effective continued or repeated treatment with PPI is often favored. However some of the patients must experience the abovementioned placebo-effect. These patients may end up being treated with PPI long-term on uncertain indication.

We wish to investigate the consequences of withdrawing treatment with PPI in patients from general practice who have previously been treated long-term.

An upper endoscopy is performed in patients who experience upper abdominal symptoms after withdrawal of treatment.If the endoscopy is normal patients are randomised to 1 week treatment with either esomeprazole or placebo.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
esomeprazole	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.

Secondary Outcomes

Measure	Description	Time Frame
Fraction of patients who are willing to withdraw treatment with PPI
Fraction of patients who experience symptoms after withdrawal of treatment.
Description of endoscopic findings in patients who have previously been treated with PPI long-term and who after withdrawal are symptomatic

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treatment with PPI in at least 4 months out of the preceding 12.
Use of PPI in the preceding 10 out of 30 days before inclusion
Age above 18 years

Exclusion Criteria:

Erosive Esophagitis
PPI-treatment as prophylaxis against gastrointestinal bleeding
PPI-treatment as prophylaxis against ulcers
PPI-treatment as prophylaxis because of NSAID-treatment
Pregnant or lactating women
Previous upper GI surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christina Reimer, MD	Contact	+45 43 23 27 79		chrrei01@glostruphosp.kbhamt.dk

Overall Officials

Name	Affiliation	Role
Peter Bytzer, ass. professor, ph.d	Glostrup University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of gastroenterology, Glostrup University Hospital	Recruiting	Glostrup Municipality		2600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D004415	Dyspepsia
D014456	Ulcer
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064098	Esomeprazole

Ancestor Terms

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided