A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Id… (NCT06899217) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
United States416 participantsStarted 2025-01-29
Plain-language summary
The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects.
The main questions it aims to answer are:
* To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo
* To evaluate the safety of CIN-102 when given to patients with idiopathic gastroparesis compared to a placebo
Participants will go through the following schedule:
* Pre-screening (1 visit)
* Screening \& Lead-In (1-2 visits)
* Will complete a Gastric Emptying Breath Test (GEBT)
* Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation.
* Lead-In Period (1 visit)
* 12-week treatment period (7 visits)
* Study drug taken twice daily by mouth
* Will complete daily diaries and other PROs as described in protocol
* 1 week follow-up (1 visit)
Researchers will compare the effects of the following treatments:
* 15 mg CIN-102, taken orally BID for 12 weeks
* 10 mg CIN-102, taken orally BID for 12 weeks
* Placebo for CIN-102, taken orally BID for 12 weeks
Who can participate
Age range
18 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
. Persistent gastrointestinal (GI) symptoms that, in the opinion of the Investigator, are consistent with gastroparesis within 6 months prior to Screening; and
. Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT) at Visit 2.
. Is not taking the agent(s) for the management of diabetes or blood glucose;
. Has been on a stable dose of the agent(s) for at least 3 months before Screening and is expected to maintain the same dose throughout the study, including during GEBT;
. Is tolerating the agent(s) well, according to the Investigator's judgment;
. In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the the agent(s); and
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
The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.
Timeframe: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline