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 days8 visits

Treatment ~ Varies

Follow Up ~ 1 week1 visit

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 gastroparesis-related symptoms as compared to baseline based on the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores

Secondary study objectives

Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline

Percentage of subjects with a history of a lack of response or who could not tolerate metoclopramide therapy or other prokinetics, who demonstrate a >30% reduction from baseline on a composite score

The percentage of symptom-free days in the ANMS GCSI-DD Total Score, a composite of the Nausea Sub-Scale and Vomiting Scores, and Sub-Scale Scores