Proton Pump Inhibitor Treatment Stop

This study has been completed.
Sponsor:
Collaborators:
Research Unit of General Practice, Odense
University of Southern Denmark
The Danish Medical Research Council
Apotekerfonden af 1991
AstraZeneca
Danish College of General Practitioners
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00120315
First received: July 8, 2005
Last updated: October 5, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Dyspepsia
Drug: esomeprazole
Procedure: Helicobacter pylori c-13 breath test
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Failure of patient perceived symptom control despite treatment with project medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gastrointestinal symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • GPs and patients satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Helicobacter pylori status [ Time Frame: At enrolement ] [ Designated as safety issue: No ]
  • Resource consumption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Days without symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Use of otc-medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Sick-leave days [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of visits to primary and secondary healthcare system [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 171
Study Start Date: December 2003
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Background:

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.

Aim/purpose:

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.

Methods:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120315

Locations
Denmark
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
AstraZeneca
Danish College of General Practitioners
Investigators
Study Director: Ove B Schaffalitzky de Muckadell, Professor Odense University Hospital
  More Information

No publications provided

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, D9612L00060, 02.04, VF 20020212
Study First Received: July 8, 2005
Last Updated: October 5, 2009
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:
dyspepsia
discontinuation
Primary health care
Helicobacter pylori
Proton Pump Inhibitor
Histamine-2-receptor-antagonist

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Histamine H2 Antagonists
Proton Pump Inhibitors
Esomeprazole
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014