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

NCT00161096 | Unknown Phase 3

• 1 other identifier: BY1023/NL503
• Study Type: interventional
• Target: 276
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

on-demand therapy; pantoprazole; gastro-oesophageal reflux disease; proton pump inhibitor; acid suppression; intermittent

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

• -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)

Interventions

pantoprazole 20 mg (drug) DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• Takeda: collaborator

MeSH Terms

Conditions

Gastroesophageal Reflux; Peptic Ulcer

Interventions

Pantoprazole; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mattijs E Numans, MD, PhD

  Julius Center for Health Sciences and Primary Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: March 1, 2004
• Study Completion: September 1, 2005
• Last Updated: February 2, 2006

Record last verified: 2004-11