NCT00120315

Brief Summary

The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease. This is evaluated in a discontinuation trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2003

Typical duration for phase_4

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

December 1, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

October 6, 2009

Status Verified

October 1, 2009

Enrollment Period

3.2 years

First QC Date

July 8, 2005

Last Update Submit

October 5, 2009

Conditions

Dyspepsia

Keywords

dyspepsiadiscontinuationPrimary health careHelicobacter pyloriProton Pump InhibitorHistamine-2-receptor-antagonist

Outcome Measures

Primary Outcomes (1)

  • Failure of patient perceived symptom control despite treatment with project medication

    12 months

Secondary Outcomes (9)

  • Gastrointestinal symptoms

    12 months

  • Quality of life

    12 months

  • GPs and patients satisfaction

    12 months

  • Helicobacter pylori status

    At enrolement

  • Resource consumption

    12 months

  • +4 more secondary outcomes

Study Arms (2)

esomeprazole

NO INTERVENTION

Long-term users continue antisecretory medication

Drug: esomeprazoleProcedure: Helicobacter pylori c-13 breath test

placebo drug

PLACEBO COMPARATOR

Long-term users are treated with placebo

Drug: esomeprazoleProcedure: Helicobacter pylori c-13 breath test

Interventions

esomeprazoleDRUG

esomeprazole, original Nexium, 40 mg pills Up to once a day

esomeprazoleplacebo drug
Helicobacter pylori c-13 breath testPROCEDURE

Breath test done at entry to find Helicobacter pylori

esomeprazoleplacebo drug

Eligibility Criteria

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

You may qualify if:

  • Use of antisecretory medication for more than 2 months during the last 6 months

You may not qualify if:

  • Malignity or severe, competing medical or psychiatric disease
  • Esophagitis (proven by endoscopy)
  • Prior complication to peptic ulcer disease
  • Alarm symptoms
  • Pregnancy or lactation
  • Allergy towards esomeprazole
  • Planned hospitalisation during study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Gastroenterology, Odense University Hospital

Odense, DK-5000, Denmark

Location

Related Publications (1)

  • Zwisler JE, Jarbol DE, Lassen AT, Kragstrup J, Thorsgaard N, Schaffalitzky de Muckadell OB. Placebo-Controlled Discontinuation of Long-Term Acid-Suppressant Therapy: A Randomised Trial in General Practice. Int J Family Med. 2015;2015:175436. doi: 10.1155/2015/175436. Epub 2015 Jul 12.

    PMID: 26246908DERIVED

MeSH Terms

Conditions

Dyspepsia

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ove B Schaffalitzky de Muckadell, Professor

    Odense University Hospital

    STUDY DIRECTOR

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

July 8, 2005

First Posted

July 15, 2005

Study Start

December 1, 2003

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

October 6, 2009

Record last verified: 2009-10

Locations

DK(1)