Gastroesophageal Reflux Disease (GERD)Phase 3NCT00261300
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
A Phase 3 study testing Pantoprazole in people with Gastroesophageal Reflux Disease (GERD) and Peptic Ulcers, run by Takeda at 1 site in Germany.
Trial summary
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD might occur when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD), Peptic Ulcers
- What is being tested?
- Pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2000to Jul 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Main Inclusion Criteria:
- Patients who completed ALTANA Pharma study BY1023/FK3006 (long-term clinical trial regarding efficacy and tolerability of Pantoprazole in patients not responding to treatment with H2-receptor antagonists or omeprazole)
- Written informed consent
Main Exclusion Criteria:
- Concomitant diseases
- Pregnant or nursing female patients; female patients of childbearing potential who are not using reliable contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD might occur when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. One of the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach touches the lining of the esophagus, causing a burning sensation in the chest or throat. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in a large proportion of patients.
Additionally, long-term treatment with proton pump inhibitors may be needed for patients with chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which is often associated with ulcers in the stomach or duodenum).
The aim of the study is to evaluate the long-term effect of pantoprazole in patients with chronic gastric acid-related complaints. The study duration consists of a 5-year treatment period. Pantoprazole will be administered once daily. The study will provide further data on long-term safety, tolerability, and efficacy of pantoprazole.
- Being tested
- Pantoprazole
- Keywords
- Gastric acid, GERD, Gastroesophageal reflux disease, Pantoprazole, Proton pump inhibitor
- 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.
PantoprazoleDrug
Long term Pantoprozole trial
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pantoprazole 40 mg Receives: Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse events, laboratory values).
Measured: 5 years
Secondary outcomes (1)
Evaluation of gastrointestinal symptoms, histological parameters.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startOct 2000
- Primary completionSep 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gorig Brunner, Prof. Dr., Principal investigator, 30659 Hannover, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261300
- Sponsor's protocol ID
- BY1023/VMG-708
- Status last verified
- Dec 2008
- First submitted
- 2 Dec 2005
- 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
- Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints
- ClinicalTrials.gov ID
- NCT00261300
- Acronym / sponsor ID
- BY1023/VMG-708
- Keywords
- Gastric acid, GERD, Gastroesophageal reflux disease, Pantoprazole, Proton pump inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 5 Dec 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.
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD might occur when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. One of the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach touches the lining of the esophagus, causing a burning sensation in the chest or throat. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in a large proportion of patients.
Additionally, long-term treatment with proton pump inhibitors may be needed for patients with chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which is often associated with ulcers in the stomach or duodenum).
The aim of the study is to evaluate the long-term effect of pantoprazole in patients with chronic gastric acid-related complaints. The study duration consists of a 5-year treatment period. Pantoprazole will be administered once daily. The study will provide further data on long-term safety, tolerability, and efficacy 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 | Experimental | Drug: PantoprazolePantoprazole 40 mg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| PantoprazoleLong term Pantoprozole trial | Drug | 1 |
Primary outcome
Safety (adverse events, laboratory values).
Time frame: 5 years
1 secondary outcome
Evaluation of gastrointestinal symptoms, histological parameters.
Time frame: 5 years
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.
Gorig Brunner, Prof. Dr. principal investigator
30659 Hannover, Germany
1 site 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 Disease (GERD) and Peptic Ulcers, run by Takeda at 1 site in Germany.
The full registered description is in the About this study section and the official record.
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 1 site 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?
Safety (adverse events, laboratory values). (time frame: 5 years). 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.