GERDPhase 3NCT00336219
Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)
A Phase 3 study testing Pantoprazole in people with GERD, run by Takeda at 40 sites in 4 countries.
Trial summary
The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- What is being tested?
- Pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 40 sitesin 4 countries
- Study dates
- Aug 2006to Apr 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
- Outpatients
- History of GERD-related symptoms for at least 6 months prior to study inclusion
- Endoscopically confirmed erosive GERD or non-erosive GERD
Main Exclusion Criteria:
- Acute peptic ulcer and/or ulcer complications
- PPIs during last 7 days prior to study start
- Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day
- Intake of PPIs in combination with antibiotics for eradication of H. pylori
Trial locations and contacts
40 sites in 4 countries.
40 sites in 4 countries
Germany23 sites
Altana Pharma/Nycomed
Amberg, 92224
Altana Pharma/Nycomed
Aschersleben, 6449
Altana Pharma/Nycomed
Berlin, 10409
Altana Pharma/Nycomed
Berlin, 12587
Altana Pharma/Nycomed
Berlin, 13581
Altana Pharma/Nycomed
Cologne, 50999
Altana Pharma/Nycomed
Cologne, 51065
Altana Pharma/Nycomed
Freising, 85356
Altana Pharma/Nycomed
Germersheim, 76726
Altana Pharma/Nycomed
Grünstadt, 67269
Altana Pharma/Nycomed
Jülich, 52428
Altana Pharma/Nycomed
Köthen, 6366
Altana Pharma/Nycomed
Künzing, 94550
Altana Pharma/Nycomed
Landsberg, 6188
Altana Pharma/Nycomed
Langen, 63225
Altana Pharma/Nycomed
Leipzig, 4105
Altana Pharma/Nycomed
Ludwigshafen, 67067
Altana Pharma/Nycomed
Lüneburg, 21335
Altana Pharma/Nycomed
Mönchengladbach, 41239
Altana Pharma/Nycomed
München, 80639
Altana Pharma/Nycomed
Potsdam-Babelsberg, 14482
Altana Pharma/Nycomed
Reinfeld, 23858
Altana Pharma/Nycomed
Saarbrücken, 66111
Hungary8 sites
Altana Pharma/Nycomed
Budapest, 1125
Altana Pharma/Nycomed
Győr, 9024
Altana Pharma/Nycomed
Hatvan, 3000
Altana Pharma/Nycomed
Kaposvár, 7400
Altana Pharma/Nycomed
Kistarcsa, 2143
Altana Pharma/Nycomed
Miskolc, 3526
Altana Pharma/Nycomed
Szentes, 6600
Altana Pharma/Nycomed
Vác, 2601
Austria5 sites
Altana Pharma/Nycomed
Feldbach, 8330
Altana Pharma/Nycomed
Graz, 8020
Altana Pharma/Nycomed
Stockerau, 2000
Altana Pharma/Nycomed
Vienna, 1140
Altana Pharma/Nycomed
Wiener Neustadt, 2700
Australia4 sites
Altana Pharma/Nycomed
Bondi Junction, NSW 2022
Altana Pharma/Nycomed
Box Hill, Victoria, 3128
Altana Pharma/Nycomed
New South Wales, 2138
Altana Pharma/Nycomed
South Australia, 5000
About this study
Official title: COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes
The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.
- Conditions
- GERD
- Being tested
- Pantoprazole
- Keywords
- GERD, Pantoprazole
- 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
Symptom Assessment after treatment with Pantoprozole 40 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | 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 assessment as measured by ReQuest™ questionnaire and investigator.
Measured: 28 days
Secondary outcomes (4)
symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator
Measured: 28 days
endoscopic healing after 28 days
Measured: 28 days
health-related quality of life after 28 days
Measured: 28 days
safety.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startAug 2006
- Primary completionNov 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerald Holtmann, Prof., Principal investigator, Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336219
- Sponsor's protocol ID
- BY1023/M3-343
- Status last verified
- Oct 2008
- First submitted
- 12 Jun 2006
- Last updated
- 7 May 2012
- Results posted
- 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
- COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes
- ClinicalTrials.gov ID
- NCT00336219
- Acronym / sponsor ID
- BY1023/M3-343
- Conditions
- GERD
- Keywords
- GERD, Pantoprazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 13 Jun 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 this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | 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 |
|---|---|---|
| PantoprazoleSymptom Assessment after treatment with Pantoprozole 40 mg | Drug | 1 |
Primary outcome
symptom assessment as measured by ReQuest™ questionnaire and investigator.
Time frame: 28 days
4 secondary outcomes
symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator
Time frame: 28 days
endoscopic healing after 28 days
Time frame: 28 days
health-related quality of life after 28 days
Time frame: 28 days
safety.
Time frame: 28 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.
Related trials for GERD
RecruitingObservational study
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Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
Gerald Holtmann, Prof. principal investigator
Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia
40 sites in 4 countries: 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 GERD, run by Takeda at 40 sites in 4 countries.
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 40 sites in Germany, Hungary, Austria, Australia. 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 assessment as measured by ReQuest™ questionnaire and investigator. (time frame: 28 days). 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.