A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
Status:
Recruiting
Trial end date:
2024-10-30
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can
help reduce the symptoms associated with diabetic gastroparesis in adult patients.
The main questions it aims to answer are:
- To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients
with diabetic gastroparesis compared to a placebo
- To evaluate the safety and tolerability of CIN-102 when given to patients with diabetic
gastroparesis compared to a placebo
Participants will go through the following schedule:
- Screening period (1-2 visits)
- Lead-in period (1 visit)
- Will complete daily diary and other Patient Reported Outcomes (PROs) as described
in the protocol to assess eligibility for continued study participation
- 12-week treatment period (5 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:
- Drug- CIN-102 Dose 1
- Drug- CIN-102 Dose 2
- Drug- Placebo