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Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis (MOMENTUM Trial)

Phase 2
Waitlist Available
Research Sponsored by Processa Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28

Summary

This trial is testing a medication called PCS12852 to see if it can help people whose stomachs don't empty food properly. The study includes patients with idiopathic and diabetic gastroparesis. PCS12852 might help by making the stomach muscles work better, so food moves out more quickly.

Eligible Conditions
  • Delayed Gastric Emptying
  • Gastroparesis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Gastric Emptying Rate From Baseline Using t50 Metric for Gastric Emptying Rate
Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate
Concentrations of PCS12852 in Plasma - AUC0-last
+1 more
Secondary study objectives
Change From Baseline in the ANMS GCSI-DD

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: PCS12852 0.5mgExperimental Treatment1 Intervention
PCS12852 0.5mg tablet
Group II: PCS12852 0.1mgExperimental Treatment1 Intervention
PCS12852 0.1mg tablet
Group III: PlaceboPlacebo Group1 Intervention
Similar in appearance to active study drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PCS12852
2022
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Processa PharmaceuticalsLead Sponsor
9 Previous Clinical Trials
354 Total Patients Enrolled
~7 spots leftby Dec 2025
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