Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120315
Status:
COMPLETED
Last Update Posted:
2009-10-06
First Post:
2005-07-08
Brief Title:
Proton Pump Inhibitor Treatment Stop
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Proton Pump Inhibitor Treatment Stop Discontinuation of Acid-suppressive Medication Among Long-term Users in a Primary Health Care Setting
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
This is evaluated in a discontinuation trial
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
Aimpurpose
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
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
Aimpurpose
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VF 20020212 | None | None | None |
| MPU 16-2003 | None | None | None |
| D9612L00060 | None | None | None |
| 0204 | None | None | None |