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

NCT ID: NCT00526006

Last Updated: 2007-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-03-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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esomeprazole

40 mg od for 8 wks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Christina Reimer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Køge

Locations

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University Hospital Køgw

Køge, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Christina Reimer, MD

Role: CONTACT

[email protected]
+45 47 32 29 51

Other Identifiers

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2006-00673-145

Identifier Type: -

Identifier Source: org_study_id