Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa … (NCT02325492) | Clinical Trial Compass
TerminatedPhase 2
Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study
Stopped: Protocol redesign
Israel10 participantsStarted 2014-10
Plain-language summary
This is a one center, Phase IIa, randomized, double blind, placebo controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects 18 to 75 years of age, with newly formed cholesterol gallstones in their gallbladder following bariatric surgery confirmed by gallbladder ultrasound ..
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female age 18 to 75 years.
. Presence of newly formed gallstones (size up to 6 mm) with or without sludge diagnosed by ultrasound within 3 or 6 months after bariatric surgery following normal ultrasound.
. Bariatric surgery conducted during the last 12 months
. Patients with "sleeve gastrectomy" or laparoscopic banding of the upper stomach will be included.
. Signature of the written informed consent.
. Negative pregnancy test at study entry for females of child bearing potential.
. Females of child bearing potential practicing reliable contraception throughout the study period (not including oral contraceptives).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete dissolution of existing gallstones proven by repeated US examined gallbladder
. Hypertensive patients must be well controlled by stable dose of anti-hypertensive medication for at least 2 months prior to screening (and the stable dose can be maintained throughout the study).
Exclusion criteria
. Patients with ultrasonography evidence of gallstones in gallbladder before having the bariatric surgery.
. Patients with no clear ultrasonography evidence of gallstones -free gallbladder during the year prior their bariatric surgery.
. Patients with ultrasonography evidence of gallstones more than 1 year following bariatric surgery.
. Patients with ultrasonography evidence of gallstones in size greater than 9 mm less than 1 year following bariatric surgery.
. Weight \>140 Kg or BMI \>40
. Known alcohol and/or any other drug abuse or dependence in the last five years
. Known history or presence of clinically significant cardiovascular, hepatic, gastrointestinal, neurologic, pulmonary, endocrine, psychiatric, neoplastic disorder or nephritic syndrome.
. History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs including bile salt metabolism (e.g. inflammatory bowel disease (IDB); previous intestinal (ileal or colonic) operation; chronic pancreatic; celiac disease or previous vagotomy