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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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
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 days
Treatment ~ Varies
Follow Up ~1 weeks
This trial's timeline: 35 days for screening, Varies for treatment, and 1 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 1
2019
Completed Phase 2
~80
CIN-102 Dose 2
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: CIN-102 Dose 1, CIN-102 Dose 2, Placebo
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size of this experiment in humans?

"Affirmative, the information on clinicaltrials.gov alludes to this study's recruitment status for participants. The trial was initially listed on March 27th 2023 and has since been updated April 14th of last year. 400 individuals across 20 sites are being sought after by researchers conducting the experiment."

Answered by AI

Is CIN-102 Dose 1 deemed to be a safe treatment for people?

"Due to the lack of existing clinical data supporting efficacy, CIN-102 Dose 1's safety rating is estimated at a 2."

Answered by AI

Is there still capacity for participation in this experiment?

"Per clinicaltrials.gov, this investigation is still looking for volunteers to participate in the trial since its first posting on March 27th 2023 and last update on April 14th 2023."

Answered by AI

How widely distributed is the Canadian trial being conducted?

"This clinical trial is currently looking for enrollees at 20 different medical sites, including Costa Mesa, Clearwater and Doral. To reduce any potential travel costs associated with joining this study it might be beneficial to choose the closest location."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Michigan
Colorado
Other
What site did they apply to?
Tandem Clinical Research - New York, NY
Phoenix Medical Research Institute, LLC
New Hope Research Development
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0

Why did patients apply to this trial?

Nothing works for me. because y have gastritis. treatment resistant gastroparesis.
PatientReceived 2+ prior treatments
I trie one medication is not work. looking to try something different.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long is the study? Is a placebo situation involved in this trial?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
  1. Smart Medical Research: < 24 hours
  2. New Hope Research Development: < 24 hours
  3. Tandem Clinical Research - New York, NY: < 48 hours
~133 spots leftby Oct 2024