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Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis
Phase 2 trial testing PCS12852 in Gastroparesis in 25 participants. Completed in 6 October 2022.
| Lead sponsor | Processa Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 9 March 2022 |
| Primary completion | 29 September 2022 |
| Estimated completion | 6 October 2022 |
| Sites | 9 locations across United States |
Processa Pharmaceuticals — full company profile →
Adults 18 to 80, any sex, with Gastroparesis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change from baseline in gastric emptying rate was determined by the AUC by Gastric Emptying Breath Test (GEBT) at Day 28 after administration of PCS12852 or placebo.
| Group | Value | 95% CI |
|---|---|---|
| PCS12852 0.1mg | 267.12 | ± 708.056 |
| PCS12852 0.5mg | 283.09 | ± 871.664 |
| Placebo | 221.74 | ± 738.728 |
Time for 50% gastric emptying (t50) metric assessed by the GEBT
| Group | Value | 95% CI |
|---|---|---|
| PCS12852 0.1mg | -4.89 | ± 12.320 |
| PCS12852 0.5mg | -26.64 | ± 14.971 |
| Placebo | -11.15 | ± 12.365 |
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
| Group | Value | 95% CI |
|---|---|---|
| PCS12852 0.1mg | 0.12211 | ± 0.039216 |
| PCS12852 0.5mg | 0.59986 | ± 0.329187 |
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
| Group | Value | 95% CI |
|---|---|---|
| PCS12852 0.1mg | 0.6331 | ± 0.27524 |
| PCS12852 0.5mg | 3.0612 | ± 1.58834 |
Change from baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD). Scores range from 0-4 for the gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting), with 4 meaning a worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| PCS12852 0.1mg | -0.02 | ± 0.141 |
| PCS12852 0.5mg | -0.69 | ± 0.171 |
| Placebo | -0.58 | ± 0.138 |
Change from baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary. Scores range from 0-4 for the gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting), with 4 meaning a worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| PCS12852 0.1mg | -0.62 | ± 0.218 |
| PCS12852 0.5mg | -1.06 | ± 0.267 |
| Placebo | -0.82 | ± 0.210 |
Change from baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary. Scores range from 0-4 for the gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting), with 4 meaning a worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| PCS12852 0.1mg | -0.57 | ± 0.237 |
| PCS12852 0.5mg | -1.12 | ± 0.290 |
| Placebo | -0.91 | ± 0.228 |
Change from baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary. Scores range from 0-4 for the gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting), with 4 meaning a worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| PCS12852 0.1mg | -0.61 | ± 0.254 |
| PCS12852 0.5mg | -1.48 | ± 0.311 |
| Placebo | -1.00 | ± 0.244 |
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
| Group | Value | 95% CI |
|---|---|---|
| PCS12852 0.1mg | 1.0987 | ± 1.23183 |
| PCS12852 0.5mg | 7.4218 | ± 7.10856 |
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
| Group | Value | 95% CI |
|---|---|---|
| PCS12852 0.1mg | 0.11984 | ± 0.068770 |
| PCS12852 0.5mg | 0.48100 | ± 0.255856 |
Time frame: Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | PCS12852 0.1mg | PCS12852 0.5mg | Placebo |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
Data from ClinicalTrials.gov NCT05270460 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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