Gastroesophageal Reflux DiseasePhase 4NCT00325676
Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)
A Phase 4 study testing Pantoprazole in people with Gastroesophageal Reflux Disease, run by Takeda at 45 sites in 4 countries.
Trial summary
The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Pantoprazole
- How many people
- 639 participants
- Where
- 45 sitesin 4 countries
- Study dates
- Jun 2006to not given
- Phase
- Phase 4
- 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
- Endoscopically confirmed GERD (Los Angeles classification A-D)
- Patients whose compliance is expected to be high with respect to the completion of the questionnaires
Main Exclusion Criteria:
- Other gastrointestinal diseases
- Severe concomitant diseases
- Proton pump inhibitors (PPIs) during last 14 days before start
- H2 receptor antagonists, prokinetics during last 7 days before study start
- Helicobacter pylori (H. pylori) eradication during last 28 days before study start
Trial locations and contacts
45 sites in 4 countries.
45 sites in 4 countries
Brazil14 sites
Altana Pharma/Nycomed
Belo Horizonte-MG, 30150270
Altana Pharma/Nycomed
Blumenau - SC, 89010906
Altana Pharma/Nycomed
Botucatu - SP, 18610970
Altana Pharma/Nycomed
Campinas - Sao Paulo, 13070040
Altana Pharma/Nycomed
Campinas - SP, 13013101
Altana Pharma/Nycomed
Curitiba - PR, 80060
Altana Pharma/Nycomed
Ilha Do Fundao - Rio de Janeiro - RJ, 21941590
Altana Pharma/Nycomed
Pinheiros Sao Paulo - SP, 1246-000
Altana Pharma/Nycomed
Porto Alegre - RS, 90035003
Altana Pharma/Nycomed
Porto Alegre-RS, 90020090
Altana Pharma/Nycomed
Porto Alegre-RS, 90610000
Altana Pharma/Nycomed
Ribeirao Preto-SP, 14048900
Altana Pharma/Nycomed
Salvador-BA, 41256900
Altana Pharma/Nycomed
São Paulo, 4024002
South Africa14 sites
Altana Pharma/Nycomed
Berea, Durban, 4000
Altana Pharma/Nycomed
Bloemfontein, 9301
Altana Pharma/Nycomed
Bloemfontein, 9317
Altana Pharma/Nycomed
Cape Town, 7530
Altana Pharma/Nycomed
Durban, 4001
Altana Pharma/Nycomed
eManzimtoti, 4126
Altana Pharma/Nycomed
Goodwood, 7460
Altana Pharma/Nycomed
Johannesburg, 2033
Altana Pharma/Nycomed
Overport, Durban, 4001
Altana Pharma/Nycomed
Panorama, 7500
Altana Pharma/Nycomed
Pinetown, 4013
Altana Pharma/Nycomed
Port Elizabeth, 6001
Altana Pharma/Nycomed
Pretoria, 48
Altana Pharma/Nycomed
Somerset West, 7130
Germany11 sites
Altana Pharma/Nycomed
Bad Schwalbach, 65307
Altana Pharma/Nycomed
Burg, 39288
Altana Pharma/Nycomed
Gardelegen, 39638
Altana Pharma/Nycomed
Königstein, 61462
Altana Pharma/Nycomed
Lübeck, 23569
Altana Pharma/Nycomed
Lüdenscheid, 58507
Altana Pharma/Nycomed
Lütjenburg, 24321
Altana Pharma/Nycomed
Nieder-Olm, 55268
Altana Pharma/Nycomed
Oelde, 59302
Altana Pharma/Nycomed
Wiesbaden, 65189
Altana Pharma/Nycomed
Wolmirstedt, 39326
Poland6 sites
Altana Pharma/Nycomed
Bydgoszcz, 85-681
Altana Pharma/Nycomed
Inowrocław, 88-100
Altana Pharma/Nycomed
Poznan, 60479
Altana Pharma/Nycomed
Siemianowice Śląskie, 41-100
Altana Pharma/Nycomed
Torun, 87-100
Altana Pharma/Nycomed
Tychy, 43-100
About this study
Official title: CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD
The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, safety, and tolerability of pantoprazole.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Pantoprazole
- Keywords
- GERD, Pantoprazole, Complete Remission
- Medical subject headings
- Gastroesophageal Reflux, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms
Secondary outcomes (2)
further efficacy criteria
safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 639 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Werner Janssen, MD, Principal investigator, 23569 Lübeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325676
- Sponsor's protocol ID
- BY1023/M3-342
- Status last verified
- Jun 2007
- First submitted
- 12 May 2006
- Last updated
- 7 May 2012
- Results posted
- No
Publications
Monnikes H, Schwan T, van Rensburg C, Straszak A, Theek C, Luhmann R, Sander P, Tholen A. Possible etiology of improvements in both quality of life and overlapping gastroesophageal reflux disease by proton pump inhibitor treatment in a prospective randomized controlled trial. BMC Gastroenterol. 2013 Oct 1;13:145. doi: 10.1186/1471-230X-13-145.
PubMed 24083350
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
- CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD
- ClinicalTrials.gov ID
- NCT00325676
- Acronym / sponsor ID
- BY1023/M3-342
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, Pantoprazole, Complete Remission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 639 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- First posted
- 15 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 this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, safety, and tolerability of pantoprazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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 |
|---|---|---|
| Pantoprazole | Drug | – |
Primary outcome
time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms
2 secondary outcomes
further efficacy criteria
safety
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.
- Derived from this study: PubMed 24083350Monnikes H, Schwan T, van Rensburg C, Straszak A, Theek C, Luhmann R, Sander P, Tholen A. Possible etiology of improvements in both quality of life and overlapping gastroesophageal reflux disease by proton pump inhibitor treatment in a prospective randomized controlled trial. BMC Gastroenterol. 2013 Oct 1;13:145. doi: 10.1186/1471-230X-13-145.
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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.
Werner Janssen, MD principal investigator
23569 Lübeck, Germany
45 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pantoprazole in people with Gastroesophageal Reflux Disease, run by Takeda at 45 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 45 sites in Brazil, South Africa, Germany, Poland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00325676, which also lists 1 linked publication.
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.