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Proton Pump Inhibitor Treatment Stop

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ClinicalTrials.gov Identifier: NCT00120315
Recruitment Status : Completed
First Posted : July 15, 2005
Last Update Posted : October 6, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Dyspepsia Drug: esomeprazole Procedure: Helicobacter pylori c-13 breath test Phase 4

Detailed Description:


Testing patients with a Helicobacter pylori (Hp) 13C-urea breath test and treatment with eradication of Hp if positive - test-and-eradicate - have proven as effective and safe as prompt endoscopy for management of dyspeptic patients in a primary health care setting. However, empirical treatment with an ulcer-healing drug is often used in dyspeptic patients, as reflected in a growing proportion of long-term users without known ulcer or gastro-oesophageal reflux disease (GORD). This group of patients contributed to 59% of the total use of acid-suppressive medication in the County of Funen in Denmark in 1997.


It is our aim to examine the need for continued medication with prescribed, acid-suppressive drugs in primary health care.

Our secondary objective is to investigate the profile of symptoms, quality of life, Hp-status, consumption of drugs and use of health care services in the same context.


To conduct a randomised, placebo-controlled, blinded, clinical discontinuation trial, 500 long-term users of acid-suppressive drugs are identified by general practitioners. Long-term use is defined as treatment for more than 2x28 days during a 6-month period. The patients are included with a 13C-urea Hp-breath test and randomised for treatment with PPI or placebo. Hp-positive patients are treated with an Hp-eradication treatment. The patients are followed for 1 year; the primary outcome is the need for open treatment with acid-suppressive medication due to failing symptom relief despite treatment with the randomised project medication. The patients are to fill in a symptom and medication diary every month for periods of 1 week. Questionnaires are to be given to the patients 3 times during the follow-up period. Medication diaries as well as questionnaires have proven useful in similar studies. The main outcome is analysed using Kaplan-Meier survival estimates analysis.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Proton Pump Inhibitor Treatment Stop: Discontinuation of Acid-suppressive Medication Among Long-term Users in a Primary Health Care Setting
Study Start Date : December 2003
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: esomeprazole
Long-term users continue antisecretory medication
Drug: esomeprazole
esomeprazole, original Nexium, 40 mg pills Up to once a day
Procedure: Helicobacter pylori c-13 breath test
Breath test done at entry to find Helicobacter pylori
Placebo Comparator: placebo drug
Long-term users are treated with placebo
Drug: esomeprazole
esomeprazole, original Nexium, 40 mg pills Up to once a day
Procedure: Helicobacter pylori c-13 breath test
Breath test done at entry to find Helicobacter pylori

Outcome Measures

Primary Outcome Measures :
  1. Failure of patient perceived symptom control despite treatment with project medication [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Gastrointestinal symptoms [ Time Frame: 12 months ]
  2. Quality of life [ Time Frame: 12 months ]
  3. GPs and patients satisfaction [ Time Frame: 12 months ]
  4. Helicobacter pylori status [ Time Frame: At enrolement ]
  5. Resource consumption [ Time Frame: 12 months ]
  6. Days without symptoms [ Time Frame: 12 months ]
  7. Use of otc-medication [ Time Frame: 12 months ]
  8. Sick-leave days [ Time Frame: 12 months ]
  9. Number of visits to primary and secondary healthcare system [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120315

Department of Medical Gastroenterology, Odense University Hospital
Odense, Denmark, DK-5000
Sponsors and Collaborators
Odense University Hospital
Research Unit of General Practice, Odense
University of Southern Denmark
The Danish Medical Research Council
Apotekerfonden af 1991
Danish College of General Practitioners
Study Director: Ove B Schaffalitzky de Muckadell, Professor Odense University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ove B. Schaffalitzky de Muckadell, prof., Odense University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00120315     History of Changes
Other Study ID Numbers: 2612-2176
MPU 16-2003
VF 20020212
First Posted: July 15, 2005    Key Record Dates
Last Update Posted: October 6, 2009
Last Verified: October 2009

Keywords provided by Odense University Hospital:
Primary health care
Helicobacter pylori
Proton Pump Inhibitor

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action