Gastroesophageal RefluxNCT00614536
Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period
An observational study of Gastroesophageal Reflux and Pharyngeal Diseases, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this observational study is to examine RSI (Reflux Symptom Index) and RFS (Reflux Finding Score) by treatment period before and after rabeprazole treatment in LaryngoPharyngeal Reflux Disease(LPRD) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux, Pharyngeal Diseases
- What is being tested?
- Rabeprazole Sodium
- Type of treatment
- Pill or oral medicine
- How many people
- 1,142 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Apr 2008
- Phase
- Observational
- 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
Study population: Among the patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux ; Patients who need rabeprazole treatment according to the doctor's discretion
Who may be able to join
- Patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux
- Patients who need rabeprazole treatment according to the doctor's discretion
- Patients who have signed an informed consent document indicating that they understand the purpose of and procedures required for the observational study and they agree to provide their information
Who cannot join
- Patients who took rabeprazole within the past one month
- Patients who are hypersensitive to any of rabeprazole or benzimidazole
- Patients with severe hepatic impairment
- Pregnant or lactating women
About this study
Official title: Observational Study: Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period
The purpose of this observational study is to examine RSI (Reflux Symptom Index) and RFS (Reflux Finding Score) by treatment period before and after rabeprazole treatment in LaryngoPharyngeal Reflux Disease(LPRD) patients.
Read the detailed description
This clinical study is a multicenter, open-label, prospective, observational study of outpatients who visit the department of otolaryngology (branch of medicine that deals with diagnosis and treatment of diseases of the ear, nose, and throat) under routine practice. This study will examine RSI (Reflux Symptom Index) and RFS (Reflux Finding Score) by treatment period (before and after rabeprazole treatment) in patients with LaryngoPharyngeal Reflux Disease(LPRD). Among the patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux, those needing rabeprazole sodium treatment according to the doctor's discretion are eligible for enrollment. This study will explore the correlation between RSI and RFS and will examine major reflux symptoms and types of lesions, to find the most reliable factors in diagnosing LPRD and judging therapeutic effectiveness of treatments. LPRD is a disease with various symptoms and causes lesions by exposing the upper respiratory system to gastric acid and stomach contents. RSI and RFS can be used to diagnose LPRD in a relatively objective manner by scoring items of symptoms and lesions particular to LPRD. Evaluations will be performed four times from baseline to week 12. Observational Study - one tablet of rabeprazole 10 mg or 20 mg once daily for 12 weeks
- Conditions
- Gastroesophageal Reflux, Pharyngeal Diseases
- Being tested
- Rabeprazole Sodium
- Keywords
- Reflux Symptom Index, Reflux Finding Score, Rabeprazole, LaryngoPharyngeal Reflux Disease, GastroEsophageal Reflux Disease
- Medical subject headings
- Gastroesophageal Reflux, Pharyngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole SodiumDrug
10mg - 20mg tablet once or twice daily for 12weeks
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Drug: Rabeprazole Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in RSI and RFS score during LPRD treatment period,
Measured: 12 weeks
Secondary outcomes (2)
Regional difference in distribution of symptoms and lesions, and in severity
Measured: 12 weeks
LRPD treatment period with rabaprazole sodium
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionApr 2008
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd. Clinical Trial, Study director, Janssen Korea, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614536
- Sponsor's protocol ID
- CR014812
- Status last verified
- Apr 2014
- First submitted
- 24 Jan 2008
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study: Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period
- ClinicalTrials.gov ID
- NCT00614536
- Acronym / sponsor ID
- CR014812
- Conditions
- Gastroesophageal Reflux, Pharyngeal Diseases
- Keywords
- Reflux Symptom Index, Reflux Finding Score, Rabeprazole, LaryngoPharyngeal Reflux Disease, GastroEsophageal Reflux Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,142 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Feb 2008 (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 this observational study is to examine RSI (Reflux Symptom Index) and RFS (Reflux Finding Score) by treatment period before and after rabeprazole treatment in LaryngoPharyngeal Reflux Disease(LPRD) patients.
Detailed description
This clinical study is a multicenter, open-label, prospective, observational study of outpatients who visit the department of otolaryngology (branch of medicine that deals with diagnosis and treatment of diseases of the ear, nose, and throat) under routine practice. This study will examine RSI (Reflux Symptom Index) and RFS (Reflux Finding Score) by treatment period (before and after rabeprazole treatment) in patients with LaryngoPharyngeal Reflux Disease(LPRD). Among the patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux, those needing rabeprazole sodium treatment according to the doctor's discretion are eligible for enrollment. This study will explore the correlation between RSI and RFS and will examine major reflux symptoms and types of lesions, to find the most reliable factors in diagnosing LPRD and judging therapeutic effectiveness of treatments. LPRD is a disease with various symptoms and causes lesions by exposing the upper respiratory system to gastric acid and stomach contents. RSI and RFS can be used to diagnose LPRD in a relatively objective manner by scoring items of symptoms and lesions particular to LPRD. Evaluations will be performed four times from baseline to week 12. Observational Study - one tablet of rabeprazole 10 mg or 20 mg once daily for 12 weeks
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: Rabeprazole Sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Among the patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux ; Patients who need rabeprazole treatment according to the doctor's discretion
Key inclusion criteria (3 listed)
- Patients who visit the department of otolaryngology with suspicious laryngopharyngeal reflux
- Patients who need rabeprazole treatment according to the doctor's discretion
- Patients who have signed an informed consent document indicating that they understand the purpose of and procedures required for the observational study and they agree to provide their information
Key exclusion criteria (4 listed)
- Patients who took rabeprazole within the past one month
- Patients who are hypersensitive to any of rabeprazole or benzimidazole
- Patients with severe hepatic impairment
- Pregnant or lactating women
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 Sodium10mg - 20mg tablet once or twice daily for 12weeks | Drug | 001 |
Primary outcome
The change from baseline in RSI and RFS score during LPRD treatment period,
Time frame: 12 weeks
2 secondary outcomes
Regional difference in distribution of symptoms and lesions, and in severity
Time frame: 12 weeks
LRPD treatment period with rabaprazole sodium
Time frame: 12 weeks
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 28 Apr 2014.
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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 Korea, Ltd. Clinical Trial study director
Janssen Korea, Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux and Pharyngeal Diseases, run by Janssen Korea, Ltd., Korea.
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 3 inclusion and 4 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 28 Apr 2014. 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.
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?
The change from baseline in RSI and RFS score during LPRD treatment period, (time frame: 12 weeks). 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 28 Apr 2014.