On-Demand Use of Pantoprazole: Determinants for Chronic Use of Acid Suppressive Medication

February 1, 2006 updated by: UMC Utrecht

Comparison of the Percentage Chronic on-Demand Users Treated With 20 Mg Pantoprazole on-Demand and Placebo o.d Versus Placebo on-Demand and 20 Mg Pantoprazole o.d. After Symptom Relief With 20 Mg Pantoprazole o.d.

The purpose of this study is to investigate several aspects of chronic use of acid suppressing medication: dependence on maintenance therapy, the possibilities for on-demand use, and predictors (patient characteristics) for daily need, for on-demand use and for termination of chronic use.

Study Overview

Detailed Description

2-5% of the general population is chronic user of acid suppressing medication (proton pump inhibitors, H2 receptor antagonists), mostly because of gastro-oesophageal reflux disease (GORD). Prescription data from health insurances show that the number of chronic users increases every year, which has large economic consequences.

There are indications however that on-demand and intermittent therapy can be as effective as daily use. No evidence exists regarding patients who are likely to benefit from intermittent, on-demand therapy or even termination.

In this study several aspects of chronic use of acid suppressive therapy are investigated in family practice patients.

Chronic users are transferred to pantoprazole 20 mg for 4 weeks. Patients with adequate relief of symptoms are randomized in two groups for a period of 13 weeks.

group 1: daily pantoprazole 20 mg, placebo on-demand (indicative for placebo-dependency) group 2: daily placebo, pantoprazole 20 mg on-demand (indicative for pharmacological dependency) Patients visit the research nurse at the beginning of the study and at week 4, 5, 10 and 17.

In this study we are looking for patient characteristics indicative for the dependency on acid suppressive drugs and for possibilities to reduce the dose of these drugs.

Furthermore, aspects described in "secondary outcomes" will be addressed.

Study Type

Interventional

Enrollment

276

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male and female (non-pregnant, non-lactating)out-patients between 18-75
  • chronic users of acid suppressive therapy for at least 180 days over the last year

Exclusion Criteria:

  • stage 3, 4 oesophagitis, Barrett's oesophagus, acute peptic ulcer
  • gastric hypersecretory condition, predominantly IBS symptoms, previous gastric/oesophageal surgery, pyloric stenosis
  • severe, unstable comorbidities
  • alarm symptoms
  • malignancies in the past 5 years
  • use of NSAID, systemic glucocorticoids, Cox-2 inhibitors, acetylsalicylic acid more than 150 mg daily, drugs with pH-dependent absorption, anticholinergics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The percentage of patients taking 6 or more tablets on-demand per week (averaged from week 5-17.

Secondary Outcome Measures

Outcome Measure
-mean weakly consumption of on-demand tablets
-percentage of patients in placebo group requiring less than 2 tablets pantoprazole per week
-proportion of patients with adequate relief per treatment group per week
-quality of life during double-blind phase (via SF-36 and QOLRAD for GERD symptom score)
-predictors of the primary outcome (age, sex, general medical and gastrointestinal history, Hp status, BMI, lifestyle factors, personality and psychological state)
-proportion of patients successfully changed from omeprazole to pantoprazole, or from 40 mg to 20 mg
-costs during all phases
-cost-effectiveness

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Study Chair: Mattijs E Numans, MD, PhD, Julius Center for Health Sciences and Primary Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (ESTIMATE)

September 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2006

Last Update Submitted That Met QC Criteria

February 1, 2006

Last Verified

November 1, 2004

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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