Chronic Use of Acid Suppressive MedicationPhase 3NCT00161096
On-Demand Use of Pantoprazole: Determinants for Chronic Use of Acid Suppressive Medication
A Phase 3 study testing pantoprazole 20 mg (drug) in people with Chronic Use of Acid Suppressive Medication and GORD, run by UMC Utrecht.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Use of Acid Suppressive Medication, GORD, GERD
- What is being tested?
- pantoprazole 20 mg (drug)
- How many people
- 276 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Sep 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this 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.
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.
Read the 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.
- Conditions
- Chronic Use of Acid Suppressive Medication, GORD, GERD, Reflux, Peptic Ulcer
- Being tested
- pantoprazole 20 mg (drug)
- Keywords
- on-demand therapy, pantoprazole, gastro-oesophageal reflux disease, proton pump inhibitor, acid suppression, intermittent
- Medical subject headings
- Gastroesophageal Reflux, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pantoprazole 20 mg (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
-proportion of patients successfully changed from omeprazole to pantoprazole, or from 40 mg to 20 mg
-costs during all phases
-cost-effectiveness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Use of Acid Suppressive MedicationStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 276 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Investigators
- Mattijs E Numans, MD, PhD, Study chair, Julius Center for Health Sciences and Primary Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161096
- Sponsor's protocol ID
- BY1023/NL503
- Status last verified
- Nov 2004
- First submitted
- 8 Sep 2005
- Last updated
- 2 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00161096
- Acronym / sponsor ID
- BY1023/NL503
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Mar 2004
- Study completion
- Sep 2005
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pantoprazole 20 mg (drug) | Drug | – |
Primary outcome
The percentage of patients taking 6 or more tablets on-demand per week (averaged from week 5-17.
8 secondary outcomes
-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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mattijs E Numans, MD, PhD study chair
Julius Center for Health Sciences and Primary Care
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pantoprazole 20 mg (drug) in people with Chronic Use of Acid Suppressive Medication and GORD, run by UMC Utrecht.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients taking 6 or more tablets on-demand per week (averaged from week 5-17.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2006.