Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD (NCT05556824) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD
United States247 participantsStarted 2023-03-03
Plain-language summary
This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the effect of MHS-1031 on heartburn-free days in subjects with GERD-related heartburn symptoms.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* In the opinion of the investigator or sub-investigators, the subject is capable of understanding and complying with protocol requirements, including compliance with completing nightly online questionnaires in one of the IRB-approved languages.
* Subject signs and dates an electronic (Screening Phase Part 1) and site-specific written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
* Ability, during Remote Screening Phase 2-Week Assessment, to complete all required online nightly RESQ-eD questionnaires, medication questionnaires, 4-item Patient Health Questionnaire for Depression and Anxiety (PHQ-4) questionnaire and Participant Global Assessment questionnaire.
* Access to a computer/tablet/phone with internet access and active email account in order to complete online questionnaires daily throughout study participation.
* Males or females ≥18 and ≤75 years of age, with a BMI ≥ 18 and \< 35 kg/m2.
* Female subjects must be postmenopausal or surgically sterile or, if of childbearing potential, must agree to use a medically acceptable form of contraception from the time of signing the informed consent form through completion of study. If only the barrier method is used, a single barrier or better is adequate. Postmenopausal women must have had ≥ 12 months of spontaneous amenorrhea. Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy, or bilateral…