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Prokinetic Agent
CIN-102 for Gastroparesis
Verified Trial
Phase 2
Recruiting
Research Sponsored by CinDome Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is a male or female ≥18 years of age
Use of motility agents (including but not limited to metoclopramide, domperidone, erythromycin, pyridostigmine, etc...)
Must not have
Pyloric injection of botulinum toxin within 6 months of Screening
Timeline
Screening 35 days
Treatment Varies
Follow Up 1 weeks
Summary
This trial seeks to evaluate if CIN-102 can reduce symptoms of diabetic gastroparesis in adults. Participants will compare effects of drug and placebo treatments over 12 weeks.
Who is the study for?
Adults over 18 with diabetic gastroparesis can join this trial. It's not for those allergic to eggs or spirulina, with non-diabetic causes of gastroparesis, using motility agents, or with recent substance abuse issues.
What is being tested?
The trial tests CIN-102 (deudomperidone) at two different doses against a placebo to see if it eases diabetic gastroparesis symptoms. Participants will take the study drug orally twice daily for 12 weeks and track their symptoms.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions to CIN-102 compared to a placebo. Side effects could range from mild digestive disturbances to more serious medication-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am currently taking medication to help with stomach or bowel movements.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a botulinum toxin injection in my pylorus in the last 6 months.
Timeline
Screening ~ 35 days8 visits
Treatment ~ Varies
Follow Up ~ 1 weeks1 visit
Screening ~ 35 days
Treatment ~ Varies
Follow Up ~1 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline based on the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores
Secondary study objectives
All endpoints that are evaluated over the last 2 weeks of the 12-week Treatment period will also be evaluated over the last 6 weeks of the 12-week Treatment period.
Change in the PGIC with each dose of CIN-102
Change in the PGIS with each dose of CIN-102
+16 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: CIN-102 Dose 2Experimental Treatment1 Intervention
Dose 2 twice daily for 12 weeks
Group II: CIN-102 Dose 1Experimental Treatment1 Intervention
Dose 1 twice daily for 12 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo twice daily for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CIN-102 Dose 2
2019
Completed Phase 2
~80
CIN-102 Dose 1
2019
Completed Phase 2
~80
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
CinDome Pharma, Inc.Lead Sponsor
2 Previous Clinical Trials
75 Total Patients Enrolled
2 Trials studying Gastroparesis
75 Patients Enrolled for Gastroparesis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a botulinum toxin injection in my pylorus in the last 6 months.I am 18 years old or older.I am currently taking medication to help with stomach or bowel movements.My gastroparesis is not caused by diabetes but another condition.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: CIN-102 Dose 2
- Group 3: CIN-102 Dose 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 35 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 91 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Weeks after you stop receiving the treatment.
Gastroparesis Patient Testimony for trial: Trial Name: NCT05832151 — Phase 2
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