PPI-Rebound-Trial. A Study of the Clinical Relevance of t... | NCT00526006

Studies
PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena

NCT00526006

Sponsor

Zealand University Hospital

Status

Unknown status

Last Update Posted

Sep 6, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Healthy

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 2007

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

Sep 2007

Primary Completion Date

Not provided

Completion Date

Mar 2008Estimated

First Submitted Date

Sep 5, 2007

First Submission Date that Met QC Criteria

Sep 5, 2007

First Posted Date

Sep 6, 2007Estimated

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

Sep 5, 2007

Last Update Posted Date

Sep 6, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is of clinical significance. In a doubleblinded and placebocontrolled study healthy volunteers are randomized to treatment with placebo or PPI + placebo. Gastrointestinal symptoms are scored once a week and.

Detailed Description

Not provided

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
esomeprazole	Drug	40 mg od for 8 wks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years +

Exclusion Criteria:

Dyspepsia, heartburn og acid regurgitation within the preceeding 4 weeks
Previous treatment with PPI og H2RA
Previous contact to doctor or hospital because of dyspepsia or reflux
Pregnancy or breast feeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

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 47 32 29 51		rkchre@ra.dk

Overall Officials

Name	Affiliation	Role
Christina Reimer, MD	University Hospital Køge	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Køgw	Recruiting	Køge		4600	Denmark

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