NCT05270460

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

A Phase 2A, Placebo-controlled, Randomized, Dose Response Study of the Safety, Pharmacokinetics and Efficacy of PCS12852 on Gastric Emptying Rate Assessed by 13C Spirulina GEBT in Patients With Moderate to Severe Gastroparesis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Processa Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled study that will compare the effect of 2 different dosage regimens of PCS12852 on gastric emptying time to placebo in both idiopathic gastroparesis (IG) and diabetic gastroparesis (DG) patients.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DRUG	PCS12852	PCS12852 oral tablet administered once daily
DRUG	Placebo	Placebo comparator oral tablet administered once daily

Timeline

• Start date: 2022-03-09
• Primary completion: 2022-09-29
• Completion: 2022-10-06
• First posted: 2022-03-08
• Last updated: 2023-07-21
• Results posted: 2023-07-21

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study