Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT05270460
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2022-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sbigora@processapharmaceuticals.com', 'phone': '410-693-6844', 'title': 'Dr. Sian Bigora', 'organization': 'Processa Pharmaceuticals Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.', 'eventGroups': [{'id': 'EG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Similar in appearance to active study drug\n\nPlacebo: Placebo comparator oral tablet administered once daily', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Similar in appearance to active study drug\n\nPlacebo: Placebo comparator oral tablet administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '267.12', 'spread': '708.056', 'groupId': 'OG000'}, {'value': '283.09', 'spread': '871.664', 'groupId': 'OG001'}, {'value': '221.74', 'spread': '738.728', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': "Adjustment for multiple comparisons were made using Dunnett's test at the overall alpha = 0.05 significance level", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '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'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '~28 days', 'description': '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.', 'unitOfMeasure': 'kPCD/minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Change in Gastric Emptying Rate From Baseline Using t50 Metric for Gastric Emptying Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Similar in appearance to active study drug\n\nPlacebo: Placebo comparator oral tablet administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.89', 'spread': '12.320', 'groupId': 'OG000'}, {'value': '-26.64', 'spread': '14.971', 'groupId': 'OG001'}, {'value': '-11.15', 'spread': '12.365', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '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'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '~28 days', 'description': 'Time for 50% gastric emptying (t50) metric assessed by the GEBT', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Concentrations of PCS12852 in Plasma - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12211', 'spread': '0.039216', 'groupId': 'OG000'}, {'value': '0.59986', 'spread': '0.329187', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile.'}, {'type': 'PRIMARY', 'title': 'Concentrations of PCS12852 in Plasma - AUC0-last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6331', 'spread': '0.27524', 'groupId': 'OG000'}, {'value': '3.0612', 'spread': '1.58834', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the ANMS GCSI-DD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Similar in appearance to active study drug\n\nPlacebo: Placebo comparator oral tablet administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '0.171', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.138', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 7', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Scores were not able to be calculated for some patients in 0.5mg group due to 2 patients discontinuing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the ANMS GCSI-DD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Similar in appearance to active study drug\n\nPlacebo: Placebo comparator oral tablet administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.218', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '0.267', 'groupId': 'OG001'}, {'value': '-0.82', 'spread': '0.210', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14', 'description': '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Scores were not able to be calculated for some patients in the 0.5mg group due to 2 patients discontinuing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the ANMS GCSI-DD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Similar in appearance to active study drug\n\nPlacebo: Placebo comparator oral tablet administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.237', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '0.290', 'groupId': 'OG001'}, {'value': '-0.91', 'spread': '0.228', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 21', 'description': '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Scores were not able to be calculated for some patients in the 0.5mg group due to 2 patients discontinuing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the ANMS GCSI-DD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Similar in appearance to active study drug\n\nPlacebo: Placebo comparator oral tablet administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.254', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '0.311', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '0.244', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 28', 'description': '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Scores were not able to be calculated for some patients in the 0.5mg group due to 2 patients discontinuing.'}, {'type': 'PRIMARY', 'title': 'Concentrations of PCS12852 in Plasma - AUC0-last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0987', 'spread': '1.23183', 'groupId': 'OG000'}, {'value': '7.4218', 'spread': '7.10856', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile.'}, {'type': 'PRIMARY', 'title': 'Concentrations of PCS12852 in Plasma - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'OG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11984', 'spread': '0.068770', 'groupId': 'OG000'}, {'value': '0.48100', 'spread': '0.255856', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'FG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Similar in appearance to active study drug\n\nPlacebo: Placebo comparator oral tablet administered once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Early Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'BG001', 'title': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet\n\nPCS12852: PCS12852 oral tablet administered once daily'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Similar in appearance to active study drug\n\nPlacebo: Placebo comparator oral tablet administered once daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Woman of Childbearing Potential', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-20', 'size': 895526, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-22T11:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2022-02-25', 'resultsFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2022-02-25', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-28', 'studyFirstPostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate', 'timeFrame': '~28 days', 'description': '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.'}, {'measure': 'Change in Gastric Emptying Rate From Baseline Using t50 Metric for Gastric Emptying Rate', 'timeFrame': '~28 days', 'description': 'Time for 50% gastric emptying (t50) metric assessed by the GEBT'}, {'measure': 'Concentrations of PCS12852 in Plasma - Cmax', 'timeFrame': 'Day 1', 'description': 'PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.'}, {'measure': 'Concentrations of PCS12852 in Plasma - AUC0-last', 'timeFrame': 'Day 1', 'description': 'PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.'}, {'measure': 'Concentrations of PCS12852 in Plasma - AUC0-last', 'timeFrame': 'Day 28', 'description': 'PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.'}, {'measure': 'Concentrations of PCS12852 in Plasma - Cmax', 'timeFrame': 'Day 28', 'description': 'PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the ANMS GCSI-DD', 'timeFrame': 'Day 7', 'description': '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.'}, {'measure': 'Change From Baseline in the ANMS GCSI-DD', 'timeFrame': 'Day 14', 'description': '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.'}, {'measure': 'Change From Baseline in the ANMS GCSI-DD', 'timeFrame': 'Day 21', 'description': '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.'}, {'measure': 'Change From Baseline in the ANMS GCSI-DD', 'timeFrame': 'Day 28', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic Gastroparesis', 'Diabetic Gastroparesis'], 'conditions': ['Gastroparesis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has documented diagnosis of moderate to severe DG or IG according to the ANMS GCSI-DD score during the Screening period (score of \\>2 on average of the screening days).\n* Moderate to severe delay in gastric emptying rate as measured by the GEBT at Screening defined as GE half-time (t1/2) ≥ the 80th percentile of normative data as determined by Cairn Diagnostics.\n* Male or female patients 18 to 80 years of age, inclusive, at baseline.\n* Has continuous moderate to severe symptoms for gastroparesis (that is, chronic postprandial fullness, abdominal pain, postprandial nausea, vomiting, loss of appetite and/or early satiety) as assessed by the investigator for at least the past 3 months.\n* Has hemoglobin A1c (BbA1c) \\< 11%.\n* Has Body Mass Index range between 18-40.\n* Women of childbearing potential must use one of the following acceptable methods of contraception throughout the study (1 month prior to Screening through 1 month after last dose of study medication): oral contraceptive medication, IUD, hormonal implants, injectable contraceptive methods, double-barrier methods, or tubal ligation.\n* Male patients must be willing to use acceptable contraceptive measures such as vasectomy or double-barrier method and refrain from sexual activity with any female who is pregnant or lactating. Female partners of study participants are asked to use acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Has acute, severe gastroenteritis and pronounced dehydration in the past 48 hours prior to Screening, chronic parenteral feeding or persistent severe vomiting.\n* Has known hypersensitivity to Spirulina, egg, milk products or wheat allergens.\n* Has a known disturbance of small intestinal absorption, exocrine pancreatic function, liver metabolism or pulmonary function.\n* Has a history of anorexia nervosa or bulimia.\n* Previous history of bezoars (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).\n* Prior surgery involving any gastrointestinal surgery, including the luminal gastrointestinal (GI) tract (cholecystectomy and appendectomy are permitted if performed \\>3 months prior to baseline GEBT).\n* Any abdominal or pelvic surgery within the past 3 months.\n* Known history of the following GI conditions: inflammatory bowel disease; irritable bowel syndrome with diarrhea; or any other active disorder that could explain symptoms in the opinion of the investigator.\n* Has active diverticulitis, diverticular stricture, and other intestinal strictures.\n* Currently taking Glucagon-like peptide-1 (GLP-1) agonists, e.g. exenatide, liraglutide, semaglutide or dulaglutide, or pramlintide.\n* Has severe psychiatric illness (including suicidal tendencies or ideation) or neurological illness.\n* Use of narcotics/opioids, drugs used to treat gastroparesis within 3 days of the Screening GEBT test.\n* Clinically significant cardiac disease including but not limited to unstable angina, acute myocardial infarction within 6 months of baseline, and arrhythmia requiring therapy.\n* Patient has QTc interval ≥ 480 milliseconds on Screening ECG.\n* History of cerebral hemorrhage, cerebrovascular accident, transient ischemic attack, gastrointestinal bleeding, or retinal hemorrhage within 6 months of baseline.\n* Patient has active or history of neoplastic disease (except for adequately treated non-invasive basal cell and/or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within the past 5 years prior to baseline.\n* Presence of clinically significant medical condition(s) including but not limited to: renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, neurological, psychiatric, substance abuse, and or any other clinically significant disease or disorder, which in the opinion of the investigator, may put the patient at risk due to participation in the study, influence the results of the study, and/or affect the patient's ability to complete the study.\n* History of or current diagnosis of active tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of the Screening Visit of a positive TB skin test with purified protein derivative with induration ≥ 5 mm, a positive QuantiFERON TB test or positive or borderline T-SPOT \\[Elispot\\] test); or positive TB test at Screening. Patients with documented completion of appropriate LTBI treatment would not be excluded and are not required to be tested.\n* Currently taking known P-gp and BCRP inhibitors or inducers and gastric acid reducing agents. E.g., proton pump inhibitors or H2 receptor antagonists.\n\nOther inclusion/exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT05270460', 'acronym': 'MOMENTUM', 'briefTitle': 'Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Processa Pharmaceuticals'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PCS12852-GP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCS12852 0.1mg', 'description': 'PCS12852 0.1mg tablet', 'interventionNames': ['Drug: PCS12852']}, {'type': 'EXPERIMENTAL', 'label': 'PCS12852 0.5mg', 'description': 'PCS12852 0.5mg tablet', 'interventionNames': ['Drug: PCS12852']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Similar in appearance to active study drug', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PCS12852', 'type': 'DRUG', 'description': 'PCS12852 oral tablet administered once daily', 'armGroupLabels': ['PCS12852 0.1mg', 'PCS12852 0.5mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo comparator oral tablet administered once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Clinical Research Institute, Inc.', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'TriWest Research Associates', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'APF Research, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33183', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'International Research Associates, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '71220', 'city': 'Bastrop', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Delta Research Partners', 'geoPoint': {'lat': 32.77828, 'lon': -91.91144}}, {'zip': '11023', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Gastrointestinal Research Group', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'M3 Wake Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Processa Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}