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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
Torrance Clinical Research Institute, Inc.
Lomita, California, United States
TriWest Research Associates
San Diego, California, United States
APF Research, LLC
Miami, Florida, United States
International Research Associates, LLC
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.
Time frame: ~28 days
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
Time frame: ~28 days
Concentrations of PCS12852 in Plasma - Cmax
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Time frame: Day 1
Concentrations of PCS12852 in Plasma - AUC0-last
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Time frame: Day 1
Concentrations of PCS12852 in Plasma - AUC0-last
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Time frame: Day 28
Concentrations of PCS12852 in Plasma - Cmax
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Time frame: Day 28
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.
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Miami, Florida, United States
University of Louisville
Louisville, Kentucky, United States
Delta Research Partners
Bastrop, Louisiana, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, United States
M3 Wake Research
Raleigh, North Carolina, United States
Texas Tech University
El Paso, Texas, United States
Time frame: Day 7
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.
Time frame: Day 14
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.
Time frame: Day 21
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.
Time frame: Day 28