Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT05832151
Brief 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 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
* 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:
* Drug- CIN-102 Dose 15 mg or 10 mg
* Drug- Placebo
Study:
NCT05832151
Study Brief:
Protocol Section:
NCT05832151