Back to search results

Fosamprenavir for Laryngopharyngeal Reflux

This study is testing a drug called fosamprenavir calcium for people with Laryngopharyngeal Reflux (LPR). LPR is a condition that causes symptoms like chronic cough and hoarseness. Current treatments often don't work well because they don't stop reflux, which involves an enzyme called pepsin. Fosamprenavir calcium is thought to work by blocking pepsin. Researchers want to see if taking 1,400 mg of fosamprenavir calcium twice daily for 12 weeks can improve your LPR symptoms. You might be able to join if you are between 18 and 64 years old, have a diagnosis of LPR, and your symptoms haven't improved with other treatments. The study will measure changes in your symptom scores to see if the treatment is successful. The current status of this study is unclear.

Study design
This is a prospective, placebo-controlled clinical trial. It plans to enroll 104 participants.
What's involved
You would take either fosamprenavir calcium or a placebo twice daily for 12 weeks. You would also have clinic visits, flexible laryngoscopy, and MII-pH testing.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be measured from the start of the study until 12 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04383262

Fosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction

Recruiting
PHASE2Ages 18–64InterventionalTreatment
Medical College of Wisconsin
~104 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:Fosamprenavir CalciumPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Reflux Symptom Index (RSI)
Measured over Baseline to 12-week post-treatment.
+1 more outcome measured

Conditions

Laryngopharyngeal Reflux

Explore related trials

Laryngopharyngeal reflux

NCT04383262

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Froedtert Hospital

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Ally Vandenberg, BSc
[email protected]
(414)955-2659
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

Contraceptive requirements Fosamprenavir may decrease the effectiveness of combined hormonal contraception through significant CYP3A4 induction of estrogen. If subjects' preferred choice of contraception is combined hormonal contraception, subjects must also agree to use a second method of contraception (condom + spermicide) during study drug treatment.
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, e.g. inflammatory bowel syndrome 7. A history of laryngeal or neck surgery including thyroidectomy and laryngomicroscopic surgery 8. Suspected esophageal cancer 9. Nasopharyngeal cancer 10. Previously undergone anti-reflux surgery 11. Polypharmacy (five or more concurrent medications due to comorbidities) 12. Any contraindications to FOS including the following:

What this trial measures

  • Change in Reflux Symptom Index (RSI)Baseline to 12-week post-treatment.

    The absolute change from baseline (i.e., Pretreatment) in symptom severity as indicated by RSI Score over time, with the primary treatment comparison at Week 12 (End of Treatment Visit)

  • Change in Daily Symptom Reflux Diary (DRSD)Baseline to 12-week post-treatment.

    The absolute change from baseline (i.e., Pretreatment) in symptom severity as indicated by Weekly Total DRSD Score (WTDS) over time, with the primary treatment comparison at Week 12 (End of Treatment Visit)