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Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis - Trial NCT05270460

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.

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NCT05270460
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05270460
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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

Study Focus

Gastroparesis

PCS12852

Interventional

drug

Sponsor & Location

Processa Pharmaceuticals

Timeline & Enrollment

Phase 2

Mar 01, 2022

Dec 01, 2022

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 gastrostomy
Gastrostomy status
Other gastritis
Gastritis, unspecified
Gastric diverticulum

Data Source

ClinicalTrials.gov

NCT05270460

Non-Device Trial