NCT00526006

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 6, 2007

Status Verified

August 1, 2007

First QC Date

September 5, 2007

Last Update Submit

September 5, 2007

Conditions

Healthy

Keywords

Clinical significance of the acid rebound phenomenon after withdrawal of treatment with a PPI

Outcome Measures

Primary Outcomes (1)

  • Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group

Interventions

esomeprazoleDRUG

40 mg od for 8 wks

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years +

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Køgw

Køge, 4600, Denmark

RECRUITING

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Christina Reimer, MD

    University Hospital Køge

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Reimer, MD

CONTACT

+45 47 32 29 51rkchre@ra.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 6, 2007

Study Start

September 1, 2007

Study Completion

March 1, 2008

Last Updated

September 6, 2007

Record last verified: 2007-08

Locations

DK(1)