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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 week

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 below
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I am 18 years old or older.
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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:
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I have not had a botulinum toxin injection in my pylorus in the last 6 months.

Timeline

Screening ~ 35 days
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 35 days for screening, Varies for treatment, and 1 week for reporting.

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 more

Trial 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

CIN-102 (Deudomperidone) (Prokinetic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05832151 — Phase 2
Gastroparesis Research Study Groups: Placebo, CIN-102 Dose 2, CIN-102 Dose 1
Gastroparesis Clinical Trial 2023: CIN-102 (Deudomperidone) Highlights & Side Effects. Trial Name: NCT05832151 — Phase 2
CIN-102 (Deudomperidone) (Prokinetic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05832151 — Phase 2
Gastroparesis Patient Testimony for trial: Trial Name: NCT05832151 — Phase 2
~155 spots leftby Nov 2025