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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161096
Recruitment Status : Unknown
Verified November 2004 by UMC Utrecht.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : February 2, 2006
Sponsor:
Collaborator:
Takeda
Information provided by:
UMC Utrecht

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date February 2, 2006
Study Start Date  ICMJE March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
The percentage of patients taking 6 or more tablets on-demand per week (averaged from week 5-17.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • -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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE On-Demand Use of Pantoprazole: Determinants for Chronic Use of Acid Suppressive Medication
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Use of Acid Suppressive Medication
  • GORD
  • GERD
  • Reflux
  • Peptic Ulcer
Intervention  ICMJE Drug: pantoprazole 20 mg (drug)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 8, 2005)
276
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161096
Other Study ID Numbers  ICMJE BY1023/NL503
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Takeda
Investigators  ICMJE
Study Chair: Mattijs E Numans, MD, PhD Julius Center for Health Sciences and Primary Care
PRS Account UMC Utrecht
Verification Date November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP