| Primary | Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate | 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. | The change from baseline to Day 28 in AUC was analyzed using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and gastroparesis type (idiopathic gastroparesis [IG] or diabetic gastroparesis [DG]) and the baseline value as a continuous covariate. Only patients with a baseline and Day 28 value were included in the analysis. The parameters listed are the best comparison of the breath test as opposed to individual timepoints. | Posted | | Least Squares Mean | Standard Error | kPCD/minutes | | ~28 days | | | | ID | Title | Description |
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| OG000 | PCS12852 0.1mg | PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG001 | PCS12852 0.5mg | PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG002 | Placebo | Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000267.12± 708.056
- OG001283.09± 871.664
- OG002221.74± 738.728
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | Fixed effects for treatment group (PCS12852 0.1 mg, PCS12852 0.5 mg, and Placebo) and type (IG or DG) and the baseline value as a continuous covariate | <0.05 | Adjustment for multiple comparisons were made using Dunnett's test at the overall alpha = 0.05 significance level | | | | | 2-Sided | 95 | | | | | | | Superiority | | |
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| Primary | Change in Gastric Emptying Rate From Baseline Using t50 Metric for Gastric Emptying Rate | Time for 50% gastric emptying (t50) metric assessed by the GEBT | The change from baseline to Day 28 using the t50 metric was analyzed using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and gastroparesis type (idiopathic gastroparesis [IG] or diabetic gastroparesis [DG]) and the baseline value as a continuous covariate. Only patients with a baseline and Day 28 value were included in the analysis. The parameters listed are the best comparison of the breath test as opposed to individual timepoints. | Posted | | Least Squares Mean | Standard Error | Minutes | | ~28 days | | | | ID | Title | Description |
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| OG000 | PCS12852 0.1mg | PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG001 | PCS12852 0.5mg | PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG002 | Placebo | Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily |
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| Primary | Concentrations of PCS12852 in Plasma - Cmax | PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted. | PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 | | | | ID | Title | Description |
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| OG000 | PCS12852 0.1mg | PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG001 | PCS12852 0.5mg | PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily |
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| Primary | Concentrations of PCS12852 in Plasma - AUC0-last | PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted. | PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile. | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 1 | | | | ID | Title | Description |
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| OG000 | PCS12852 0.1mg | PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG001 | PCS12852 0.5mg | PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily |
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| Secondary | Change From Baseline in the ANMS GCSI-DD | 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. | Scores were not able to be calculated for some patients in 0.5mg group due to 2 patients discontinuing. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Day 7 | | | | ID | Title | Description |
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| OG000 | PCS12852 0.1mg | PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG001 | PCS12852 0.5mg | PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG002 | Placebo | Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily |
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| Secondary | Change From Baseline in the ANMS GCSI-DD | 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. | Scores were not able to be calculated for some patients in the 0.5mg group due to 2 patients discontinuing. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Day 14 | | | | ID | Title | Description |
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| OG000 | PCS12852 0.1mg | PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG001 | PCS12852 0.5mg | PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG002 | Placebo | Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily |
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| Secondary | Change From Baseline in the ANMS GCSI-DD | 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. | Scores were not able to be calculated for some patients in the 0.5mg group due to 2 patients discontinuing. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Day 21 | | | | ID | Title | Description |
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| OG000 | PCS12852 0.1mg | PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG001 | PCS12852 0.5mg | PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG002 | Placebo | Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily |
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| Secondary | Change From Baseline in the ANMS GCSI-DD | 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. | Scores were not able to be calculated for some patients in the 0.5mg group due to 2 patients discontinuing. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | PCS12852 0.1mg | PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG001 | PCS12852 0.5mg | PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG002 | Placebo | Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily |
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| Primary | Concentrations of PCS12852 in Plasma - AUC0-last | PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted. | PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile. | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 28 | | | | ID | Title | Description |
|---|
| OG000 | PCS12852 0.1mg | PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG001 | PCS12852 0.5mg | PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily |
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| Primary | Concentrations of PCS12852 in Plasma - Cmax | PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted. | PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile. | Posted | | Mean | Standard Deviation | ng/mL | | Day 28 | | | | ID | Title | Description |
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| OG000 | PCS12852 0.1mg | PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily | | OG001 | PCS12852 0.5mg | PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily |
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