NCT00915239

Brief Summary

The purpose of this study is to determine whether proton pump inhibitor (PPI) induced hypersecretion leads to acid related symptoms after treatment in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
Last Updated

June 5, 2009

Status Verified

June 1, 2009

Enrollment Period

9 months

First QC Date

June 4, 2009

Last Update Submit

June 4, 2009

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

  • To evaluate whether healthy volunteers, treated with PPI for four weeks, develop acid-related symptoms after cessation of PPI therapy.

Secondary Outcomes (1)

  • To evaluate whether there is a correlation between markers for acid secretion such as gastrin and chromogranin-A and the development of dyspeptic symptoms.

Study Arms (2)

Pantoprazole

ACTIVE COMPARATOR
Drug: Pantoprazole

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PantoprazoleDRUG

40 mg pantoprazole once daily for 28 days

Pantoprazole
PlaceboDRUG

identical placebo once daily for 28 days

Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers
  • years of age
  • Informed consent
  • No prior history of any GI disorder

You may not qualify if:

  • Dyspeptic complaints
  • H. pylori infection
  • Ongoing treatment with pain-relieving medications (i.e., NSAID)
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska Univeristy Hospital

Gothenburg, Gothenburg, 413 45, Sweden

Location

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 5, 2009

Study Start

January 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

June 5, 2009

Record last verified: 2009-06

Locations

SE(1)