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PCS12852 for 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
Has documented diagnosis of moderate to severe DG or IG according to the ANMS GCSI-DD score during the Screening period (score of >2 on average of the screening days).
Moderate to severe delay in gastric emptying rate as measured by the GEBT at Screening defined as GE half-time (t1/2) ≥ the 80th percentile of normative data as determined by Cairn Diagnostics.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights
MOMENTUM Trial Summary
This trial will compare the effects of two dosages of PCS12852 on gastric emptying time in patients with idiopathic or diabetic gastroparesis, versus placebo.
MOMENTUM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMOMENTUM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Change From Baseline in the ANMS GCSI-DD
MOMENTUM 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
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Who is running the clinical trial?
Processa PharmaceuticalsLead Sponsor
8 Previous Clinical Trials
283 Total Patients Enrolled
Frequently Asked Questions
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