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

GERD Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00161096
• Other study ID #: BY1023/NL503
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: February 1, 2006
• Start date: March 2004
• Est. completion date: September 2005

Study information

• Verified date: November 2004
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 276
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• pantoprazole 20 mg (drug)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients taking 6 or more tablets on-demand per week (averaged from week 5-17.
Secondary	-mean weakly consumption of on-demand tablets
Secondary	-percentage of patients in placebo group requiring less than 2 tablets pantoprazole per week
Secondary	-proportion of patients with adequate relief per treatment group per week
Secondary	-quality of life during double-blind phase (via SF-36 and QOLRAD for GERD symptom score)
Secondary	-predictors of the primary outcome (age, sex, general medical and gastrointestinal history, Hp status, BMI, lifestyle factors, personality and psychological state)
Secondary	-proportion of patients successfully changed from omeprazole to pantoprazole, or from 40 mg to 20 mg
Secondary	-costs during all phases
Secondary	-cost-effectiveness