An observational study in Laryngopharyngeal Reflux (LPR), Extraesophageal Reflux and Reflux Laryngitis, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Northwestern University · Observational
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Among 26 studies in Laryngopharyngeal Reflux with a site in United States — 3 open to participants now, 4 under way, none of them phase 3. Laryngopharyngeal Reflux · United States.
Among the 26 studies in Laryngopharyngeal Reflux with a site in United States, this one is the only one that started in 2012, is one of 5 observational ones, and was the 13th registered.
56 studies on the registry are indexed under Laryngopharyngeal Reflux; 8 are open to participants now.
Browse Laryngopharyngeal Reflux studies →3 of the 26 studies in Laryngopharyngeal Reflux with a site in United States are open now. Recruiting first, the newest first:
Medical College of Wisconsin · Sites in United States
Ages 18–64
University of California, San Diego · Sites in United States
Ages 18–89
Johns Hopkins University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 5 Laryngopharyngeal Reflux studies recruiting now, 1 sets no upper age limit and 2 stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years to 89 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 2 · Phase 4 7
First in 2003; this study’s year is marked. 1 started in 2012.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 43 across the 21 interventional studies, 45 across the 5 observational. Of the 15 that completed or were terminated, 8 (53%) have results posted.
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4 of 26 have an industry lead sponsor. The 10 most frequent:
Northwestern University is the lead sponsor of 1,424 studies on the registry; 199 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Northwestern University has 2 studies filed under Laryngopharyngeal Reflux — fewer than ten, so there is no comparison to draw.
1 of the studies in Laryngopharyngeal Reflux with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04383262Medical College of WisconsinFosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction | 2027-07-01 |
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Among the 26 studies in Laryngopharyngeal Reflux with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this research study is to better understand whether information obtained from a pH probe can help physicians predict whether a patient will respond to the medication that is prescribed for laryngopharyngeal reflux (LPR). The current treatment given to individuals who are diagnosed with LPR is a course of proton pump inhibitor (PPI) medication. Subjects who agree to participate in this study will have a small flexible tube (about the width of a piece of cooked spaghetti) placed in their throat. This tube measures the pH in the throat over a period of 24 hours and helps physicians study the relationship between pH level, LPR symptoms, and the effectiveness of PPI therapy. This study may help physicians find out if certain symptoms or characteristics can help them predict if the PPI medication will be effective for each patient. After probe removal, subjects will receive compensation. They will return to the clinic at their regularly scheduled follow-up visit with the physician, 8 to 12 weeks after starting the PPI medication. At that time, subjects can choose to participate in an optional probe placement.
The purpose of this research study is to better understand whether information obtained from a pH probe can help physicians predict whether a patient will respond to the medication that is prescribed for laryngopharyngeal reflux (LPR). The current treatment given to individuals who are diagnosed with LPR is a course of proton pump inhibitor (PPI) medication. This medication reduces the amount of gastric acid that is produced and generally leads to symptom relief. In order to study whether the pH probe can help physicians predict if the patient will respond to PPI therapy, the physicians will measure the pH level of patients' throats before they start PPI medication. Subjects who agree to participate in this study will have a small flexible tube (about the width of a piece of uncooked spaghetti) placed in their throat. The physician will place the tube through the nose until the tip is in the back of the throat, high enough so that the patient will not feel it when they talk, eat, drink, or swallow. This tube measures the pH in the throat over a period of 24 hours and helps physicians study the relationship between pH level, LPR symptoms, and the effectiveness of PPI therapy. This study may help physicians find out if certain symptoms or characteristics can help them predict if the PPI medication will be effective for each patient. After probe removal, subjects will receive compensation. They will return to the clinic at their regularly scheduled follow-up visit with the physician, 8 to 12 weeks after starting the PPI medication. At that time, subjects can choose to participate in an optional probe placement.
People receiving care at Northwestern Medicine for laryngeal symptoms
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Restech pH probe placement at initial clinic visit; subject returns 24 hrs later for probe removal. 2. Proton pump inhibitor (PPI) therapy; subject starts PPI medication (omeprazole 40mg once daily) and returns for follow-up visit 8-12 weeks later. 3. Optional second pH probe placement at follow up visit; Subject returns 24 hours later for probe removal; Subject continues PPI medication for 2 more weeks
RSI Score
Change from baseline in RSI score at 8-12 weeks after initial clinic visit/initiation of treatment will be used to define a response to PPI therapy
Time frame: 8-12 weeks after initial clinic visit
Global improvement in self-reported symptoms
Change from baseline in global improvement in self-reported symptoms at 8-12 weeks after initial clinic visit/initiation of treatment will be used to define response to PPI therapy
Time frame: 8-12 weeks after initial clinic visit
Differences in pH between PPI responders and non-responders
The Ryan score, total time (as a percent) and number of events below a pH of 4, 5, 6, and 7 will be compared between PPI responders and non-responders.
Time frame: 8-12 weeks after initial clinic visit
Effects of PPI therapy on reflux events
All subjects will have the option of a second pH probe placement at the follow up clinic visit 8-12 weeks after the initial clinic visit to assess the effects of PPI therapy on reflux events.
Time frame: 8-12 weeks after initial clinic visit
The record gives a start of Aug 2012, a primary completion of Nov 2014 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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