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New treatment option for Laryngopharyngeal Reflux
Official title Fosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction
ClinicalTrials.gov ID: NCT04383262
What this study is testing
What is Fosamprenavir Calcium?
Fosamprenavir Calcium is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for laryngopharyngeal reflux.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Laryngopharyngeal Reflux (LPR) is a common condition that causes symptoms like chronic cough, throat clearing, hoarseness, and trouble swallowing. If not treated, LPR can lead to long-term throat damage and may increase the risk of throat cancer.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- 1\. Clinical diagnosis of LPR 2. Age ≥ 18 years 3. RSI \> 13 4. RFS \> 7 5. Documented LPR by MII-pH testing (\> 1 proximal event) 6. Failed 3 month...
- Hepatic Function Panel must be within normal limits
- Results from V1 safety labs must all be within normal limits
- Patient agrees not to make any changes to their usual diet and/or anti-reflux medications during the study.
- Patient is compliant with eDiary completion; that is, they have completed the eDiary questions on at least 5 days each week during the 14 calendar...
You likely can't join if
- Age ≥ 65 years 2. Patient is not fluent and literate in English. 3. Pregnant (or plan to be) and nursing mothers 4. Women of child-bearing potential...
- Contraceptive requirements Fosamprenavir may decrease the how well it works of combined hormonal contraception through significant CYP3A4 induction...
- Medroxyprogesterone acetate injectable
- Intrauterine Device
- Female Sterilization
- Male Sterilization 4. Currently being treated with another investigational medical device and/or drug 5. A history of gastric or esophageal surgery...
See the full eligibility criteria
- 1\. Clinical diagnosis of LPR 2. Age ≥ 18 years 3. RSI \> 13 4. RFS \> 7 5. Documented LPR by MII-pH testing (\> 1 proximal event) 6. Failed 3 month bid PPI therapy 7. Attending laryngology clinic with study providers...
- Hepatic Function Panel must be within normal limits
- Results from V1 safety labs must all be within normal limits
- Patient agrees not to make any changes to their usual diet and/or anti-reflux medications during the study.
- Patient is compliant with eDiary completion; that is, they have completed the eDiary questions on at least 5 days each week during the 14 calendar days before the start of the Treatment Period.
- Patient is compliant with continuing any current PPI (if using) during the 14 calendar days before the start of the Treatment Period. Patients are considered compliant if, as reported in the daily eDiary, they continued...
- Age ≥ 65 years 2. Patient is not fluent and literate in English. 3. Pregnant (or plan to be) and nursing mothers 4. Women of child-bearing potential not willing to comply with contraceptive requirements during the study...
- Contraceptive requirements Fosamprenavir may decrease the how well it works of combined hormonal contraception through significant CYP3A4 induction of estrogen. If people' preferred choice of contraception is combined...
- Medroxyprogesterone acetate injectable
- Intrauterine Device
- Female Sterilization
- Male Sterilization 4. Currently being treated with another investigational medical device and/or drug 5. A history of gastric or esophageal surgery 6. Gastrointestinal disease that might interfere symptom questionnaire...
- Ownership of an electronic with access to internet websites and email required to conduct the DRSD, PGI-S, and PGI-C
- Internet access
- A valid email address for notifications
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.