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

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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

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.

Condition or disease Intervention/treatment Phase
Chronic Use of Acid Suppressive Medication GORD GERD Reflux Peptic Ulcer Drug: pantoprazole 20 mg (drug) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : March 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. -mean weakly consumption of on-demand tablets
  2. -percentage of patients in placebo group requiring less than 2 tablets pantoprazole per week
  3. -proportion of patients with adequate relief per treatment group per week
  4. -quality of life during double-blind phase (via SF-36 and QOLRAD for GERD symptom score)
  5. -predictors of the primary outcome (age, sex, general medical and gastrointestinal history, Hp status, BMI, lifestyle factors, personality and psychological state)
  6. -proportion of patients successfully changed from omeprazole to pantoprazole, or from 40 mg to 20 mg
  7. -costs during all phases
  8. -cost-effectiveness


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161096


Sponsors and Collaborators
UMC Utrecht
Takeda
Investigators
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Study Chair: Mattijs E Numans, MD, PhD Julius Center for Health Sciences and Primary Care
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ClinicalTrials.gov Identifier: NCT00161096    
Other Study ID Numbers: BY1023/NL503
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 2, 2006
Last Verified: November 2004
Keywords provided by UMC Utrecht:
on-demand therapy
pantoprazole
gastro-oesophageal reflux disease
proton pump inhibitor
acid suppression
intermittent
Additional relevant MeSH terms:
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Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action