Gastroesophageal RefluxPhase 4NCT00216489
A Study of the Safety of Rabeprazole Administered to Adults With Gastroesophageal Reflux Disease (GERD)
A Phase 4 study testing rabeprazole sodium in people with Gastroesophageal Reflux and Heartburn, 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 patients with erosive or ulcerative gastroesophageal reflux disease (GERD) in routine primary health care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux, Heartburn
- What is being tested?
- rabeprazole sodium
- How many people
- 191 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Nov 2005
- 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
Who may be able to join
- Patients with symptoms of erosive or ulcerative gastroesophageal reflux disease (GERD) during at least a period of 3 months prior to study initiation and symptoms of GERD for at least 3 days per week within the 2 weeks prior to study initiation. The symptoms of erosive or ulcerative gastroesophageal reflux disease includes the following: heartburn, aching behind the breastbone, a need for antacids, and difficulty in swallowing. Patients with evidence by endoscopy of erosive or ulcerative gastroesophageal reflux disease with no Barret-type tissue transformation.
Who cannot join
- No narrowing or inflammation of the esophagus
- no known gastro-duodenal ulcer
- no infections (other than H. Pylori), inflammations or hemorrhage of the stomach, small or large intestine
- no prior surgery of the stomach or intestine
- no known history of primary kinetic disorders of the esophagus, other than GERD
- no history of enlarged veins of the esophagus or stomach
- no pregnant or nursing females, or those lacking adequate contraception.
About this study
Official title: A Non Interventional Post Authorization Safety Study (PASS) On The Rabeprazole's Administration To Adults With Gastro-Oesophageal Reflux Disease (GORD)
The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the treatment of patients with erosive or ulcerative gastroesophageal reflux disease (GERD) in routine primary health care.
Read the detailed description
Gastroesophageal reflux can result in mild to severe symptoms in some persons. Heartburn, a burning sensation or discomfort rising behind the breastbone, is a common symptom. Gastroesophageal reflux disease (GERD) can be described as a condition with clearly identified clinical symptoms or the change in tissue structure that results from the reflux of contents from the stomach or small intestine into the esophagus. This is a study to confirm the safety and effectiveness of rabeprazole in the treatment of patients with GERD in routine primary health care. The study has two phases. Patients will receive treatment with rabeprazole tablets once daily for 8 weeks. In the second phase, patients will be monitored by their physician for a follow up period to end of study (12 months). Safety assessments include the incidence of adverse events throughout the treatment and follow up phases, and physical examination and laboratory tests at end of treatment and after 4 months. Assessments of effectiveness include the degree of relief of symptoms at beginning and end of treatment and at specific intervals during follow up. The study hypothesis is that rabeprazole is well-tolerated with long term treatment of patients with GERD in routine primary health care. Rabeprazole tablet (20 milligrams[mg]) once daily in the morning for 8 weeks. Dose may be increased to 2 tablets daily (40 mg maximum) at investigator's discretion.
- Conditions
- Gastroesophageal Reflux, Heartburn
- Being tested
- rabeprazole sodium
- Keywords
- gastroesophageal reflux, heartburn, rabeprazole, GERD, anti-ulcer agents, proton pump inhibitor
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
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 treatment (8 weeks) and follow up (12 months)
Secondary outcomes (1)
Severity of symptoms at baseline and specified intervals during treatment and follow up, rated from "no problem" to "very severe problem"; physical examination and laboratory tests at end of treatment and after 4 months
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 startMar 2003
- Study completionNov 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 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
- NCT00216489
- Sponsor's protocol ID
- CR003502
- 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
- A Non Interventional Post Authorization Safety Study (PASS) On The Rabeprazole's Administration To Adults With Gastro-Oesophageal Reflux Disease (GORD)
- ClinicalTrials.gov ID
- NCT00216489
- Acronym / sponsor ID
- CR003502
- Conditions
- Gastroesophageal Reflux, Heartburn
- Keywords
- gastroesophageal reflux, heartburn, rabeprazole, GERD, anti-ulcer agents, proton pump inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., GreeceIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Nov 2005 (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 patients with erosive or ulcerative gastroesophageal reflux disease (GERD) in routine primary health care.
Detailed description
Gastroesophageal reflux can result in mild to severe symptoms in some persons. Heartburn, a burning sensation or discomfort rising behind the breastbone, is a common symptom. Gastroesophageal reflux disease (GERD) can be described as a condition with clearly identified clinical symptoms or the change in tissue structure that results from the reflux of contents from the stomach or small intestine into the esophagus. This is a study to confirm the safety and effectiveness of rabeprazole in the treatment of patients with GERD in routine primary health care. The study has two phases. Patients will receive treatment with rabeprazole tablets once daily for 8 weeks. In the second phase, patients will be monitored by their physician for a follow up period to end of study (12 months). Safety assessments include the incidence of adverse events throughout the treatment and follow up phases, and physical examination and laboratory tests at end of treatment and after 4 months. Assessments of effectiveness include the degree of relief of symptoms at beginning and end of treatment and at specific intervals during follow up. The study hypothesis is that rabeprazole is well-tolerated with long term treatment of patients with GERD in routine primary health care. Rabeprazole tablet (20 milligrams[mg]) once daily in the morning for 8 weeks. Dose may be increased to 2 tablets daily (40 mg maximum) at investigator's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptoms of erosive or ulcerative gastroesophageal reflux disease (GERD) during at least a period of 3 months prior to study initiation and symptoms of GERD for at least 3 days per week within the 2 weeks prior to study initiation. The symptoms of erosive or ulcerative gastroesophageal reflux disease includes the following: heartburn, aching behind the breastbone, a need for antacids, and difficulty in swallowing. Patients with evidence by endoscopy of erosive or ulcerative gastroesophageal reflux disease with no Barret-type tissue transformation.
Key exclusion criteria (7 listed)
- No narrowing or inflammation of the esophagus
- no known gastro-duodenal ulcer
- no infections (other than H. Pylori), inflammations or hemorrhage of the stomach, small or large intestine
- no prior surgery of the stomach or intestine
- no known history of primary kinetic disorders of the esophagus, other than GERD
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 treatment (8 weeks) and follow up (12 months)
1 secondary outcome
Severity of symptoms at baseline and specified intervals during treatment and follow up, rated from "no problem" to "very severe problem"; physical examination and laboratory tests at end of treatment and after 4 months
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 Gastroesophageal Reflux and Heartburn, 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 1 inclusion and 7 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 treatment (8 weeks) and follow up (12 months). 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.