CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
PCS12852 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05270460
NCT05270460Phase 2Completed

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·interventional·Posted Mar 8, 2022·Updated Jul 21, 2023

In Brief

A Phase 2 clinical trial evaluating PCS12852 and Placebo for Gastroparesis. Completed, enrolled 25 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroparesis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMar 8, 2022
Enrollment StartMar 9, 2022
Primary CompletionSep 29, 2022
Study CompletionOct 6, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.3 years ago

Interventions

PCS12852drug

PCS12852 oral tablet administered once daily

Placebodrug

Placebo comparator oral tablet administered once daily