Gastroesophageal RefluxNCT00517114
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
A study testing Rabeprazole 20mg twice daily in people with Gastroesophageal Reflux and Laryngitis, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of rabeprazole (pariet) versus placebo in treating reflux laryngitis in Chinese patients. Patients who attend the voice clinic of Department of ENT, Queen Mary hospital with suspected reflux laryngitis will be recruited. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux, Laryngitis
- What is being tested?
- Rabeprazole 20mg twice daily
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2005to Dec 2008
- Phase
- Interventional
- 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 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Ambulatory patients with age between 18-80 years old
- Patients with newly presented laryngitis.
Who cannot join
- They were under 18 or over 80 years of age
- Has significant concomitant medical disease
- Pregnancy or lactating women
- Chronic cough attributable to known chronic pulmonary or tracheobronchial disease
- Previous glottal surgery, radiotherapy or malignancy
- Acid suppressive therapy within 4 wk prior to recruitment
Show all 9Show fewer
- Pharyngo-laryngeal infection in the previous 3 months
- Tracheal intubation in previous 12 months
- Immunosuppression and use of inhaled corticosteroid
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy of rabeprazole (pariet) versus placebo in treating reflux laryngitis in Chinese patients. Patients who attend the voice clinic of Department of ENT, Queen Mary hospital with suspected reflux laryngitis will be recruited. A questionnaire will be administered by the research assistant of the Department of Medicine and ENT, Queen Mary hospital. A 12-week course of PPI versus placebo trial will be commenced and patients' symptoms and signs will be documented at 6-week and 12-week time. The study will finish after a 12-week course of rabeprazole.
- Conditions
- Gastroesophageal Reflux, Laryngitis
- Being tested
- Rabeprazole 20mg twice daily
- Keywords
- Reflux laryngitis
- Medical subject headings
- Gastroesophageal Reflux, Laryngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole 20mg twice dailyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms assessment, quality of life.
Measured: 12 weeks
Secondary outcomes (2)
Compliance
Measured: 4 weeks
Adverse effects
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startJan 2005
- Study completionDec 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- The University of Hong Kong
- Investigators
- Paul KY Lam, Dr, Principal investigator, Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517114
- Sponsor's protocol ID
- UW04-204 T/526
- Other IDs
- HARECCTR0500033
- Status last verified
- Oct 2013
- First submitted
- 15 Aug 2007
- Last updated
- 23 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
- ClinicalTrials.gov ID
- NCT00517114
- Acronym / sponsor ID
- UW04-204 T/526
- Conditions
- Gastroesophageal Reflux, Laryngitis
- Keywords
- Reflux laryngitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- The University of Hong Kong
- Study start
- Jan 2005
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Aug 2007 (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 study is to evaluate the efficacy of rabeprazole (pariet) versus placebo in treating reflux laryngitis in Chinese patients. Patients who attend the voice clinic of Department of ENT, Queen Mary hospital with suspected reflux laryngitis will be recruited. A questionnaire will be administered by the research assistant of the Department of Medicine and ENT, Queen Mary hospital. A 12-week course of PPI versus placebo trial will be commenced and patients' symptoms and signs will be documented at 6-week and 12-week time. The study will finish after a 12-week course of rabeprazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ambulatory patients with age between 18-80 years old
- Patients with newly presented laryngitis.
Key exclusion criteria (9 listed)
- They were under 18 or over 80 years of age
- Has significant concomitant medical disease
- Pregnancy or lactating women
- Chronic cough attributable to known chronic pulmonary or tracheobronchial disease
- Previous glottal surgery, radiotherapy or malignancy
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 20mg twice daily | Drug | – |
Primary outcome
Symptoms assessment, quality of life.
Time frame: 12 weeks
2 secondary outcomes
Compliance
Time frame: 4 weeks
Adverse effects
Time frame: 4 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 23 Oct 2013.
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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.
Paul KY Lam, Dr principal investigator
Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rabeprazole 20mg twice daily in people with Gastroesophageal Reflux and Laryngitis, run by Hospital Authority, Hong Kong at 1 site in China.
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 2 inclusion and 9 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 23 Oct 2013. 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 China. 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.
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?
Symptoms assessment, quality of life. (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 23 Oct 2013.