Helicobacter InfectionsPhase 4NCT00216450
Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults.
A Phase 4 study testing rabeprazole sodium in people with Helicobacter Infections and Bacterial Infections, run by Janssen Cilag Pharmaceutica S.A.C.I., Greece.
Trial summary
The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the treatment of adult patients with Helicobacter pylori (H. pylori) infection in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Helicobacter Infections, Bacterial Infections
- What is being tested?
- rabeprazole sodium
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Feb 2006
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with Helicobacter pylori (H. pylori) infection
- patients over 45 years of age must have an endoscopic examination of the digestive system
- patients must have positive result of urea breath test (UBT) for H. pylori
- patients being treated with rabeprazole in combination with clarithromycin and amoxycillin to eradicate H. pylori.
Who cannot join
- Known hypersensitivity to rabeprazole, clarithromycin, or amoxycillin
- evidence from endoscopic examination of gastrointestinal hemorrhage or stomach cancer, or had previous stomach surgery
- use of aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, bismuth, or proton pump inhibitors during the last 4 weeks prior to study initiation
- history of successful treatment to eradicate H.pylori infection
- females who are pregnant or nursing
About this study
Official title: An Open Observational Study For The Rabeprazole Administration In Adult Subjects With Helicobacter Pylori (H. Pylori) Infection
The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the treatment of adult patients with Helicobacter pylori (H. pylori) infection in routine clinical practice.
Read the detailed description
An infection of Helicobacter pylori (H. pylori) is a risk factor for many types of gastrointestinal diseases and associated with stomach inflammation, ulcer of the stomach or small intestine. The recommended treatment for the infection is a triple therapy consisted of one proton pump inhibitor, such as rabeprazole, and two antibiotics administered for 7 days. This is an open label, nonrandomized study of the safety of rabeprazole in the treatment of patients with H. pylori infection. The study consists of 2 phases: the 2-month main phase and the 4-month monitoring phase (total duration of 6 months). During the main phase, patients are treated for 7 days with three drugs (rabeprazole, clarithromycin, and amoxycillin), and the effectiveness of the treatment is assessed 4 weeks later. During the monitoring phase, patients are interviewed at monthly intervals to assess symptoms and to report any adverse events. Safety assessments include the incidence of adverse events throughout the treatment and monitoring phases, and laboratory tests (hematology, biochemistry, urinalysis) and vital signs at the start of the study and after 1 month. Assessments of effectiveness include the eradication of H. pylori infection, assessed by the urea breath test one month after treatment. The primary study hypothesis is that rabeprazole is well-tolerated long-term in the treatment of patients with H. pylori infection in routine clinical practice. Rabeprazole tablets (20 milligrams[mg]) taken orally twice daily for 7 days. Clarithromycin (500mg) and amoxycillin (1 gram) taken twice daily for 7 days.
- Conditions
- Helicobacter Infections, Bacterial Infections
- Being tested
- rabeprazole sodium
- Keywords
- rabeprazole, proton pump inhibitor, Helicobacter infections, Helicobacter pylori, H pylori, bacterial infections
- Medical subject headings
- Helicobacter Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazole sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events throughout the study
Secondary outcomes (1)
Laboratory tests (hematology, biochemistry, urinalysis) and vital signs at start of study and one month after treatment; eradication of H. pylori infection, assessed by urea breath test one month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., Greece
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial, Study director, Janssen-Cilag Pharmaceutica S.A.C.I.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216450
- Sponsor's protocol ID
- CR003478
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 26 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Observational Study For The Rabeprazole Administration In Adult Subjects With Helicobacter Pylori (H. Pylori) Infection
- ClinicalTrials.gov ID
- NCT00216450
- Acronym / sponsor ID
- CR003478
- Conditions
- Helicobacter Infections, Bacterial Infections
- Keywords
- rabeprazole, proton pump inhibitor, Helicobacter infections, Helicobacter pylori, H pylori, bacterial infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., GreeceIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 22 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 the study is to confirm the safety and effectiveness of rabeprazole in the treatment of adult patients with Helicobacter pylori (H. pylori) infection in routine clinical practice.
Detailed description
An infection of Helicobacter pylori (H. pylori) is a risk factor for many types of gastrointestinal diseases and associated with stomach inflammation, ulcer of the stomach or small intestine. The recommended treatment for the infection is a triple therapy consisted of one proton pump inhibitor, such as rabeprazole, and two antibiotics administered for 7 days. This is an open label, nonrandomized study of the safety of rabeprazole in the treatment of patients with H. pylori infection. The study consists of 2 phases: the 2-month main phase and the 4-month monitoring phase (total duration of 6 months). During the main phase, patients are treated for 7 days with three drugs (rabeprazole, clarithromycin, and amoxycillin), and the effectiveness of the treatment is assessed 4 weeks later. During the monitoring phase, patients are interviewed at monthly intervals to assess symptoms and to report any adverse events. Safety assessments include the incidence of adverse events throughout the treatment and monitoring phases, and laboratory tests (hematology, biochemistry, urinalysis) and vital signs at the start of the study and after 1 month. Assessments of effectiveness include the eradication of H. pylori infection, assessed by the urea breath test one month after treatment. The primary study hypothesis is that rabeprazole is well-tolerated long-term in the treatment of patients with H. pylori infection in routine clinical practice. Rabeprazole tablets (20 milligrams[mg]) taken orally twice daily for 7 days. Clarithromycin (500mg) and amoxycillin (1 gram) taken twice daily for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients diagnosed with Helicobacter pylori (H. pylori) infection
- patients over 45 years of age must have an endoscopic examination of the digestive system
- patients must have positive result of urea breath test (UBT) for H. pylori
- patients being treated with rabeprazole in combination with clarithromycin and amoxycillin to eradicate H. pylori.
Key exclusion criteria (5 listed)
- Known hypersensitivity to rabeprazole, clarithromycin, or amoxycillin
- evidence from endoscopic examination of gastrointestinal hemorrhage or stomach cancer, or had previous stomach surgery
- use of aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, bismuth, or proton pump inhibitors during the last 4 weeks prior to study initiation
- history of successful treatment to eradicate H.pylori infection
- females who are pregnant or nursing
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 |
|---|---|---|
| rabeprazole sodium | Drug | – |
Primary outcome
Incidence of adverse events throughout the study
1 secondary outcome
Laboratory tests (hematology, biochemistry, urinalysis) and vital signs at start of study and one month after treatment; eradication of H. pylori infection, assessed by urea breath test one month after treatment
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 26 Apr 2010.
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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.
Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial study director
Janssen-Cilag Pharmaceutica S.A.C.I.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rabeprazole sodium in people with Helicobacter Infections and Bacterial Infections, run by Janssen Cilag Pharmaceutica S.A.C.I., Greece.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Apr 2010. 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 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?
Incidence of adverse events throughout the study. 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 26 Apr 2010.