Pure Global
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
Processa Pharmaceuticals·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Gastroparesis
Drug/Device/Intervention
PCS12852
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Processa Pharmaceuticals
Timeline & enrollment
Phase
Phase 2
Start date
Mar 01, 2022
End date
Dec 01, 2022
Enrollment
24 participants
Primary outcome

Change in gastric emptying rate from baseline as determined by the AUC of the gastric emptying rate,Change in gastric emptying rate from baseline using t10 and t50 metric for gastric emptying rate,Concentrations of PCS12852 in plasma

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.

ICD-10 classifications
Attention to gastrostomyGastrostomy statusOther gastritisGastritis, unspecifiedGastric diverticulum
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05270460
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05270460 through Pure Global AI's free database. This Phase 2 trial is sponsored by Processa Pharmaceuticals and is currently Not yet recruiting. The study focuses on Gastroparesis. Target enrollment is 24 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.