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

NCT ID: NCT00161096

Last Updated: 2006-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2005-09-30

Brief Summary

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.

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.

Conditions

Chronic Use of Acid Suppressive Medication; GORD; GERD; Reflux; Peptic Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

pantoprazole 20 mg (drug)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Principal Investigators

Mattijs E Numans, MD, PhD

Role: STUDY_CHAIR

Julius Center for Health Sciences and Primary Care

Other Identifiers

BY1023/NL503

Identifier Type: -

Identifier Source: org_study_id