Laryngopharyngeal RefluxPhase 3NCT01450748
Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux
A Phase 3 study testing Sodium alginate in people with Laryngopharyngeal Reflux, run by TTY Biopharm at 1 site in Taiwan.
Trial summary
Laryngopharyngeal reflux (LPR), the backflow of gastric acid into the larynx and hypopharynx, is a contributing factor to hoarseness, throat clearing, throat pain, and globus sensation. The therapeutic effect of proton pump inhibitors (PPIs) is controversial because a high placebo effect can be observed. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Laryngopharyngeal Reflux
- What is being tested?
- Sodium alginate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2011to Mar 2015
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with age of 12-75 years old (inclusive)
- Patients with at least one symptom consistent with LPR, including hoarseness, throat clearing, throat pain, globus sensation in the throat, or chronic cough ≧ 4 weeks before entering study
- Patients with a total reflux symptom index (RSI) >10 (based on a self-administered 9-item questionnaire of voice/throat complaints)
- Patients with a total reflux finding score (RFS) >5 (based on a laryngoscopic examination by investigators)
- Patients or their legal representatives have signed the informed consent form
Who cannot join
- Patients with viral or bacterial laryngitis, or occupational exposures causing laryngitis
- Patients with erosive GERD as evidenced by upper GI endoscopy
- Patients with laryngeal or hypopharyngeal cancer, esophageal or gastric cancer, , or with history of neck radiation therapy
- Patients with history of uncontrolled hypertension or moderate to severe renal impairment
- Patients with history of esophageal or gastric surgery
- Patients with active pulmonary infection (pneumonia, tuberculosis) as evidenced by chest X-ray
Show all 12Show fewer
- Patients with endotracheal tube intubation within 2 months before entering study
- Patients had taken any alginate preparations within 2 days; H2-blocker, prokinetic agent or antacid within 7 days; or proton pump inhibitors (PPIs) within 14 days before screening
- Patients with a history of allergy to the study drugs or their related compounds
- Patients with a history of alcohol or drug abuse, or with any psychiatric disease
- Patients participated any investigational drug trial within 4 weeks before entering the study
- Patients with any other conditions or diseases that investigator considers it is not appropriate to enter the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Alginos Oral Suspension (Sodium Alginate 50 mg/ml) for the Treatment of Patients With Laryngopharyngeal Reflux (LPR)
Laryngopharyngeal reflux (LPR), the backflow of gastric acid into the larynx and hypopharynx, is a contributing factor to hoarseness, throat clearing, throat pain, and globus sensation. The therapeutic effect of proton pump inhibitors (PPIs) is controversial because a high placebo effect can be observed. Sodium Alginate is an effective medication indicated for symptomatic treatment of gastroesophageal reflux. This randomized, double-blind, placebo-controlled study aims to evaluate the efficacy and safety profile of sodium alginates oral suspension (50 mg/ml) 20 ml 3 times daily for the treatment of with LPR patients in Taiwan. Efficacy assessments include mean reduction in the total reflux symptom index (RSI) score after 4 and 8 weeks treatment, mean reduction in the total reflux finding score (RFS) after 4 and 8 weeks treatment, mean changes in the total numbers of reflux episodes as measured by 24-hour ambulatory combined impedance-pH monitoring after 1 day and 8 weeks treatment. Safety assessments include incidence of adverse events. The study hypothesis is sodium alginate is superior over placebo in relieving LPR symptoms.
Read the detailed description
This double-blind, randomized, placebo-controlled trial aims to evaluate the efficacy and safety profiles of sodium alginate oral suspension (50mg/ml) 20ml 3 times daily for the treatment of patients with laryngopharyngeal reflux (LPR) in Taiwan. Patients will be enrolled into study if they are at the age of 12 to 75 years old, have at least one symptom consistent with LPR and lasting for more than 4 weeks before study, with a total reflux symptom index (RSI)>10, with a total reflux finding score (RFS)>5, and have signed the informed consent form. Patients will be excluded if they are diagnosed as erosive gastroesophageal reflux disease (GERD)as evidenced by upper GI endoscopy, viral or bacterial laryngitis, or occupational exposures causing laryngitis, laryngeal or hypopharyngeal cancer, esophageal or gastric cancer, with history of neck radiation therapy, with history of esophageal or gastric surgery, with active pulmonary infection (pneumonia, tuberculosis) as evidenced by chest X-ray, with endotracheal tube intubation within 2 months before entering study, or taking any alginate preparations within 2 days; H2-blocker, prokinetic agent or antacid within 7 days; or proton pump inhibitors (PPIs) within 14 days before screening. The primary efficacy endpoint is mean reduction in the total RSI from baseline to Week 8. The secondary efficacy endpoints are mean reduction in the total RSI from baseline to Day 2 and Week 4; mean reduction in the RFS from baseline to Week 4 and Week 8; mean change in the individual component of RSI from baseline to Day 2 , Week 4 and Week 8; mean change in the individual component of RFS from baseline to Week 4 and Week 8; and mean change in the total numbers of reflux episodes as measured by 24-hr ambulatory combined impedance-pH monitoring from baseline to day 2 and week 8. The safety endpoint is incidence of adverse events. The study hypothesis is that sodium alginate is superior over placebo in treating patients with LPR.
- Conditions
- Laryngopharyngeal Reflux
- Being tested
- Sodium alginate, Placebo
- Keywords
- sodium alginate, laryngopharyngeal reflux, combined impedance-pH monitoring
- Medical subject headings
- Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium alginateDrug
Also called Alginos
oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks
PlaceboDrug
matching placebo oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sodium alginate | Experimental | oral suspension, 50 mg/ml Receives: Drug: Sodium alginate |
| Placebo | Placebo comparator | oral suspension without active ingredient Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction in the total reflux symptom index (RSI) score from baseline to Week 8
RSI is a self-administered 9-item questionnaire. RSI can be completed in less than 1 minute. The scale for each individual item ranges from 0 (no problem) to 5 (severe problem), with a maximum total score of 45. A total RSI score of >10 is suggestive of laryngopharyngeal reflux
Measured: before and after 8 weeks treatment
Secondary outcomes (1)
Mean reduction in the total reflux symptom index (RSI) score from baseline to Day 2 and Week 4
Measured: before and after 1 day and 4 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngopharyngeal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- TTY Biopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tzu-Yu Hsiao, Ph.D., Principal investigator, Department of Ear, Nose and Throat, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450748
- Sponsor's protocol ID
- TTYALG1101
- Other IDs
- NTUH-IRB-201106058MA
- Status last verified
- Jun 2015
- First submitted
- 7 Oct 2011
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Alginos Oral Suspension (Sodium Alginate 50 mg/ml) for the Treatment of Patients With Laryngopharyngeal Reflux (LPR)
- ClinicalTrials.gov ID
- NCT01450748
- Acronym / sponsor ID
- TTYALG1101
- Conditions
- Laryngopharyngeal Reflux
- Keywords
- sodium alginate, laryngopharyngeal reflux, combined impedance-pH monitoring
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TTY BiopharmIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 Oct 2011 (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.
Laryngopharyngeal reflux (LPR), the backflow of gastric acid into the larynx and hypopharynx, is a contributing factor to hoarseness, throat clearing, throat pain, and globus sensation. The therapeutic effect of proton pump inhibitors (PPIs) is controversial because a high placebo effect can be observed. Sodium Alginate is an effective medication indicated for symptomatic treatment of gastroesophageal reflux. This randomized, double-blind, placebo-controlled study aims to evaluate the efficacy and safety profile of sodium alginates oral suspension (50 mg/ml) 20 ml 3 times daily for the treatment of with LPR patients in Taiwan. Efficacy assessments include mean reduction in the total reflux symptom index (RSI) score after 4 and 8 weeks treatment, mean reduction in the total reflux finding score (RFS) after 4 and 8 weeks treatment, mean changes in the total numbers of reflux episodes as measured by 24-hour ambulatory combined impedance-pH monitoring after 1 day and 8 weeks treatment. Safety assessments include incidence of adverse events. The study hypothesis is sodium alginate is superior over placebo in relieving LPR symptoms.
Detailed description
This double-blind, randomized, placebo-controlled trial aims to evaluate the efficacy and safety profiles of sodium alginate oral suspension (50mg/ml) 20ml 3 times daily for the treatment of patients with laryngopharyngeal reflux (LPR) in Taiwan. Patients will be enrolled into study if they are at the age of 12 to 75 years old, have at least one symptom consistent with LPR and lasting for more than 4 weeks before study, with a total reflux symptom index (RSI)>10, with a total reflux finding score (RFS)>5, and have signed the informed consent form. Patients will be excluded if they are diagnosed as erosive gastroesophageal reflux disease (GERD)as evidenced by upper GI endoscopy, viral or bacterial laryngitis, or occupational exposures causing laryngitis, laryngeal or hypopharyngeal cancer, esophageal or gastric cancer, with history of neck radiation therapy, with history of esophageal or gastric surgery, with active pulmonary infection (pneumonia, tuberculosis) as evidenced by chest X-ray, with endotracheal tube intubation within 2 months before entering study, or taking any alginate preparations within 2 days; H2-blocker, prokinetic agent or antacid within 7 days; or proton pump inhibitors (PPIs) within 14 days before screening. The primary efficacy endpoint is mean reduction in the total RSI from baseline to Week 8. The secondary efficacy endpoints are mean reduction in the total RSI from baseline to Day 2 and Week 4; mean reduction in the RFS from baseline to Week 4 and Week 8; mean change in the individual component of RSI from baseline to Day 2 , Week 4 and Week 8; mean change in the individual component of RFS from baseline to Week 4 and Week 8; and mean change in the total numbers of reflux episodes as measured by 24-hr ambulatory combined impedance-pH monitoring from baseline to day 2 and week 8. The safety endpoint is incidence of adverse events. The study hypothesis is that sodium alginate is superior over placebo in treating patients with LPR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium alginate | Experimental | Drug: Sodium alginateoral suspension, 50 mg/ml |
| Placebo | Placebo comparator | Drug: Placebooral suspension without active ingredient |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with age of 12-75 years old (inclusive)
- Patients with at least one symptom consistent with LPR, including hoarseness, throat clearing, throat pain, globus sensation in the throat, or chronic cough ≧ 4 weeks before entering study
- Patients with a total reflux symptom index (RSI) >10 (based on a self-administered 9-item questionnaire of voice/throat complaints)
- Patients with a total reflux finding score (RFS) >5 (based on a laryngoscopic examination by investigators)
- Patients or their legal representatives have signed the informed consent form
Key exclusion criteria (12 listed)
- Patients with viral or bacterial laryngitis, or occupational exposures causing laryngitis
- Patients with erosive GERD as evidenced by upper GI endoscopy
- Patients with laryngeal or hypopharyngeal cancer, esophageal or gastric cancer, , or with history of neck radiation therapy
- Patients with history of uncontrolled hypertension or moderate to severe renal impairment
- Patients with history of esophageal or gastric surgery
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 |
|---|---|---|
| Sodium alginateAlso: Alginosoral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks | Drug | Sodium alginate |
| Placebomatching placebo oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks | Drug | Placebo |
Primary outcome
Mean reduction in the total reflux symptom index (RSI) score from baseline to Week 8
Time frame: before and after 8 weeks treatment
RSI is a self-administered 9-item questionnaire. RSI can be completed in less than 1 minute. The scale for each individual item ranges from 0 (no problem) to 5 (severe problem), with a maximum total score of 45. A total RSI score of >10 is suggestive of laryngopharyngeal reflux
1 secondary outcome
Mean reduction in the total reflux symptom index (RSI) score from baseline to Day 2 and Week 4
Time frame: before and after 1 day and 4 weeks 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 8 Jun 2015.
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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.
Tzu-Yu Hsiao, Ph.D. principal investigator
Department of Ear, Nose and Throat, National Taiwan University Hospital
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 Sodium alginate in people with Laryngopharyngeal Reflux, run by TTY Biopharm at 1 site in Taiwan.
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 5 inclusion and 12 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 8 Jun 2015. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Mean reduction in the total reflux symptom index (RSI) score from baseline to Week 8 (time frame: before and after 8 weeks treatment). 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 8 Jun 2015.