Phase 2 Gastro-oesophageal Reflux Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been clinically diagnosed with laryngopharyngeal reflux (LPR), which is a condition where stomach acid travels up to the throat
• People who are 18 years of age or older (but under 65)
• People whose symptom scores on two specific reflux questionnaires (called the RSI and RFS) are above certain thresholds, indicating notable symptoms and throat findings (confirm with trial site)
• People whose LPR has been confirmed by a specialised reflux monitoring test (called MII-pH testing) showing acid travelling up to the throat
• People who have already tried standard acid-blocking medication (PPIs, taken twice daily) for at least 3 months without enough improvement
• People who are already attending a laryngology clinic with the study doctors and who have had a throat camera examination and reflux monitoring test as part of their usual care, with at least three months between clinic visits
• People whose liver function blood test results are within normal range (required before continuing in the study after early visits)
• People whose other safety blood test results from an early study visit are all within normal limits
• People who agree not to change their usual diet or reflux medications during the study
• People who have consistently completed a daily electronic diary (on at least 5 days per week in the 2 weeks before starting treatment)
• People who have continued taking their current acid-blocking medication as usual (if they are on one) during the 2 weeks before starting treatment, as recorded in the daily diary
• People who own a device with internet and email access, as the study requires completing digital questionnaires online
• People who have a valid email address for study notifications

Who may not be able to join:

• People who are 65 years of age or older
• People who are not fluent and literate in English
• People who are pregnant, planning to become pregnant, or are currently breastfeeding
• Women who could potentially become pregnant and are not willing to follow the contraception requirements during the study and for one week after the last dose of study medication — this includes using a second method of contraception (condom and spermicide) if combined hormonal contraception is the preferred method, as the study drug may reduce its effectiveness (confirm with trial site)
• People who are currently taking part in another clinical trial involving an investigational drug or medical device
• People who have had surgery on their stomach or oesophagus (the food pipe)
• People with a gastrointestinal condition (such as inflammatory bowel disease) that could affect how symptoms are reported on questionnaires
• People who have had surgery on their voice box or neck, including thyroid or throat surgery
• People with suspected oesophageal (food pipe) cancer
• People with nasopharyngeal (upper throat/nasal passage) cancer
• People who have previously had surgery specifically to treat reflux
• People taking five or more regular medications at the same time for other health conditions
• People who have had a serious allergic reaction to the study drug or its related compounds
• People currently taking certain medications that interact dangerously with the study drug, including some heart, psychiatric, cholesterol, sedative, and other specific medications — a full list would need to be reviewed by the trial site (confirm with trial site)
• People not willing to avoid eating grapefruit or Seville oranges for five days before starting the study drug through to the final study visit
• People taking other foods or medications listed as prohibited in the study protocol (confirm with trial site)
• People who are unlikely to understand or follow the study requirements, in the opinion of the study doctor
• People with a history of liver disease or impairment
• People with a sulfa (sulfonamide) allergy
• People with haemophilia
• People with active tuberculosis (TB) or a history of active TB
• People with a history of latent TB (a non-active TB infection) unless they have completed a full documented course of preventive treatment
• People with a history of HIV infection or who test positive for HIV
• People who test positive for hepatitis B or C, or who are taking certain hepatitis C treatment medications
• People not willing to avoid taking biotin-containing supplements for at least 12 hours before their first study visit
• People with any other ongoing health condition that, in the study doctor's opinion, would prevent them from safely completing the trial
• People who do not have access to a device with internet access and a valid email address

Important: Always verify eligibility with the trial site directly before applying.