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

Sponsor:	UMC Utrecht
Collaborator:	ALTANA Pharma
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00161096

Purpose

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.

Condition	Intervention	Phase
Chronic Use of Acid Suppressive Medication GORD GERD Reflux Peptic Ulcer	Drug: pantoprazole 20 mg (drug)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

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

Secondary Outcome Measures:

-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

Estimated Enrollment:	276
Study Start Date:	March 2004
Estimated Study Completion Date:	September 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161096

Sponsors and Collaborators

UMC Utrecht

ALTANA Pharma

Investigators

Study Chair:

Mattijs E Numans, MD, PhD

Julius Center for Health Sciences and Primary Care

More Information

No publications provided

Study ID Numbers:	BY1023/NL503
Study First Received:	September 8, 2005
Last Updated:	February 1, 2006
ClinicalTrials.gov Identifier:	NCT00161096 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:

on-demand therapy
pantoprazole
gastro-oesophageal reflux disease

proton pump inhibitor
acid suppression
intermittent

Additional relevant MeSH terms:

Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
Pantoprazole
Anti-Ulcer Agents

Gastrointestinal Agents
Intestinal Diseases
Pharmacologic Actions
Duodenal Diseases
Peptic Ulcer

ClinicalTrials.gov processed this record on November 22, 2009