Proton Pump Inhibitor Treatment Stop
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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 |
- Failure of patient perceived symptom control despite treatment with project medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 |
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| Denmark | |
| Department of Medical Gastroenterology, Odense University Hospital | |
| Odense, Denmark, DK-5000 | |
| 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 Omeprazole Proton Pump Inhibitors Histamine Antagonists Histamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on October 16, 2012
