Gastroesophageal RefluxPhase 3NCT00326027
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)
A Phase 3 study testing Pantoprazole in people with Gastroesophageal Reflux, run by Nycomed at 35 sites in Germany.
Trial summary
The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux disease, Los Angeles [LA] Grade A-D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 35 sitesGermany
- Study dates
- Oct 2006to Nov 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Written informed consent
- Inpatients (hospitalization during the entire study period is mandatory)
- Symptomatic (heartburn, acid regurgitation or dysphagia for at least 1 day since admission to the hospital) non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD, LA Grade A-D)
Main Exclusion Criteria:
- Known Zollinger-Ellison syndrome or other gastric hypersecretory condition
- Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy)
- On initial endoscopy, presence of obstructive esophageal strictures, Schatzki's ring, esophageal diverticula, esophageal varices, achalasia or Barrett's esophagus with known high-grade dysplasia or longer than 3 cm
- Acute peptic ulcer and/or ulcer complications
- Pyloric stenosis
- Known inflammatory bowel diseases
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Germany35 sites
Nycomed Deutschland GmbH
Augsburg, 86156
Nycomed Deutschland GmbH
Berlin, 10117
Nycomed Deutschland GmbH
Brandenburg, 14770
Nycomed Deutschland GmbH
Cologne, 51067
Nycomed Deutschland GmbH
Cologne, 51109
Nycomed Deutschland GmbH
Erlangen, 91054
Nycomed Deutschland GmbH
Frankfurt, 60488
Nycomed Deutschland GmbH
Frankfurt, 60569
Nycomed Deutschland GmbH
Gera, 07548
Nycomed Deutschland GmbH
Göttingen, 37075
Nycomed Deutschland GmbH
Greifswald, 17489
Nycomed Deutschland GmbH
Halle, 06110
Nycomed Deutschland GmbH
Hamburg, 21075
Nycomed Deutschland GmbH
Hamburg, 22457
Nycomed Deutschland GmbH
Ingolstadt, 85049
Nycomed Deutschland GmbH
Jena, 07747
Nycomed Deutschland GmbH
Kassel, 34125
Nycomed Deutschland GmbH
Kiel, 24105
Nycomed Deutschland GmbH
Leipzig, 04103
Nycomed Deutschland GmbH
Lübeck, 23538
Nycomed Deutschland GmbH
Ludwigsburg, 71640
Nycomed Deutschland GmbH
Ludwigshafen, 67063
Nycomed Deutschland GmbH
Mainz, 55131
Nycomed Deutschland GmbH
Marburg, 35043
Nycomed Deutschland GmbH
Minden, 32427
Nycomed Deutschland GmbH
München, 81377
Nycomed Deutschland GmbH
Münster, 48149
Nycomed Deutschland GmbH
Neubrandenburg, 17036
Nycomed Deutschland GmbH
Offenbach, 63069
Nycomed Deutschland GmbH
Oldenburg, 26133
Nycomed Deutschland GmbH
Recklinghausen, 45655
Nycomed Deutschland GmbH
Rostock, 18057
Nycomed Deutschland GmbH
Stade, 21682
Nycomed Deutschland GmbH
Weimar, 99425
Nycomed Deutschland GmbH
Wiesbaden, 65189
About this study
Official title: Profi-Study: Symptom Reduction in Hospitalized Patients Suffering From Symptomatic Non-erosive or Erosive Gastroesophageal Reflux Disease Treated With Pantoprazole 20 or 40 mg o.d. for 7 Days
The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™). The study duration consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered once daily in the morning to patients with NERD or GERD at one dose level for each indication. The study will provide further data on the safety and tolerability of pantoprazole.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Pantoprazole
- Keywords
- GERD, Pantoprazole, NERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Efficacy of Pantoprazole
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pantoprazole 20 mg Receives: Drug: Pantoprazole |
| 2 | Active comparator | Pantoprazole 40 mg Receives: Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment
Measured: 1 day
Secondary outcomes (3)
Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment
Measured: 7 days
Symptom relief rates as measured by ReQuest™ after 7 days of treatment
Measured: 7 days
Safety
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joachim Mössner, Prof., Principal investigator, Universitätsklinikum Leipzig, Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326027
- Sponsor's protocol ID
- BY1023/DE-004
- Status last verified
- May 2012
- First submitted
- 15 May 2006
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profi-Study: Symptom Reduction in Hospitalized Patients Suffering From Symptomatic Non-erosive or Erosive Gastroesophageal Reflux Disease Treated With Pantoprazole 20 or 40 mg o.d. for 7 Days
- ClinicalTrials.gov ID
- NCT00326027
- Acronym / sponsor ID
- BY1023/DE-004
- Conditions
- Gastroesophageal Reflux
- Keywords
- GERD, Pantoprazole, NERD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 16 May 2006 (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 aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™). The study duration consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered once daily in the morning to patients with NERD or GERD at one dose level for each indication. The study will provide further data on the safety and tolerability of pantoprazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: PantoprazolePantoprazole 20 mg |
| 2 | Active comparator | Drug: PantoprazolePantoprazole 40 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PantoprazoleEfficacy of Pantoprazole | Drug | 1, 2 |
Primary outcome
Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment
Time frame: 1 day
3 secondary outcomes
Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment
Time frame: 7 days
Symptom relief rates as measured by ReQuest™ after 7 days of treatment
Time frame: 7 days
Safety
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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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.
Joachim Mössner, Prof. principal investigator
Universitätsklinikum Leipzig, Leipzig, Germany
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pantoprazole in people with Gastroesophageal Reflux, run by Nycomed at 35 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment (time frame: 1 day). 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 7 May 2012.