Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT00845858
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2009-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcarlson@evokepharma.com', 'phone': '858-345-1494', 'title': 'Marilyn R. Carlson', 'organization': 'Evoke Pharma'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured.', 'description': 'All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event.\n\nAll serious and related AEs that occurred within 30 days after the last dose of study drug were captured.', 'eventGroups': [{'id': 'EG000', 'title': 'Metoclopramide Nasal Spray 10 mg', 'description': 'metoclopramide: 30 minutes before meals and at bedtime for 4 weeks', 'otherNumAtRisk': 95, 'otherNumAffected': 53, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metoclopramide Nasal Spray 14 mg', 'description': 'metoclopramide: 30 minutes before meals and at bedtime for 4 weeks', 'otherNumAtRisk': 95, 'otherNumAffected': 57, 'seriousNumAtRisk': 95, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 30 minutes before meals and at bedtime', 'otherNumAtRisk': 95, 'otherNumAffected': 53, 'seriousNumAtRisk': 95, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Dysguesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dry Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Blood Glucose Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Electrocardiogram Qt Prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Glycosylated Haemoglobin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pollakiurua', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Seasonal Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Non cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Metoclopramide Nasal Spray 10 mg', 'description': 'metoclopramide: 30 minutes before meals and at bedtime for 4 weeks'}, {'id': 'OG001', 'title': 'Metoclopramide Nasal Spray 14 mg', 'description': 'metoclopramide: 30 minutes before meals and at bedtime for 4 weeks'}, {'id': 'OG002', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 30 minutes before meals and at bedtime'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in male and female subjects receiving metoclopramide nasal spray versus subjects receiving placebo.\n\nThe mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).\n\n1. Nausea (feeling sick to your stomach as if you were going to vomit or throw up)\n2. Early satiety (not able to finish a normal sized meal)\n3. Bloating (feeling like you need to loosen clothes)\n4. Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.\n\nA mean change (improvement) of \\>1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Pre-specified Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score by Gender.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Female-Metoclopramide Nasal Spray 10 mg', 'description': 'metoclopramide: 30 minutes before meals and at bedtime for 4 weeks'}, {'id': 'OG001', 'title': 'Female-Metoclopramide Nasal Spray 14 mg', 'description': 'metoclopramide: 30 minutes before meals and at bedtime for 4 weeks'}, {'id': 'OG002', 'title': 'Female-Placebo Nasal Spray', 'description': 'Placebo: 30 minutes before meals and at bedtime'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.79', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in Female subjects receiving metoclopramide nasal spray versus Female subjects receiving placebo.\n\nThe mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).\n\n1. Nausea (feeling sick to your stomach as if you were going to vomit or throw up)\n2. Early satiety (not able to finish a normal sized meal)\n3. Bloating (feeling like you need to loosen clothes)\n4. Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.\n\nA mean change (improvement) of \\>1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metoclopramide Nasal Spray 10 mg', 'description': 'metoclopramide: 30 minutes before meals and at bedtime for 4 weeks'}, {'id': 'FG001', 'title': 'Metoclopramide Nasal Spray 14 mg', 'description': 'metoclopramide: 30 minutes before meals and at bedtime for 4 weeks'}, {'id': 'FG002', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 30 minutes before meals and at bedtime'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '95 subjects received allocated intervention.\n\n1 subject withdrew consent and was not dosed.', 'groupId': 'FG000', 'numSubjects': '96'}, {'comment': '95 subjects received allocated intervention.\n\n1 subject was not eligible and was not dosed.', 'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'not eligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '287', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Metoclopramide Nasal Spray 10 mg', 'description': 'metoclopramide: 30 minutes before meals and at bedtime for 4 weeks'}, {'id': 'BG001', 'title': 'Metoclopramide Nasal Spray 14 mg', 'description': 'metoclopramide: 30 minutes before meals and at bedtime for 4 weeks'}, {'id': 'BG002', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 30 minutes before meals and at bedtime'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '12.13', 'groupId': 'BG000'}, {'value': '50.3', 'spread': '12.40', 'groupId': 'BG001'}, {'value': '52.4', 'spread': '10.03', 'groupId': 'BG002'}, {'value': '51.4', 'spread': '11.56', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'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': '81', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '287', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Provides at least 80% power (alpha=0.05 two sided) to detect a mean difference between treatment groups of 0.5, for the GCSI-DD total score. Based on the literature, the standard deviation (SD) of the endpoint is approximately 1.1 resulting in a sample size of 77 per treatment group.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-17', 'studyFirstSubmitDate': '2009-02-17', 'resultsFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-16', 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Pre-specified Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score by Gender.', 'timeFrame': '4 weeks', 'description': 'Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in Female subjects receiving metoclopramide nasal spray versus Female subjects receiving placebo.\n\nThe mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).\n\n1. Nausea (feeling sick to your stomach as if you were going to vomit or throw up)\n2. Early satiety (not able to finish a normal sized meal)\n3. Bloating (feeling like you need to loosen clothes)\n4. Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.\n\nA mean change (improvement) of \\>1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful.'}], 'primaryOutcomes': [{'measure': 'The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score.', 'timeFrame': '4 weeks', 'description': 'Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in male and female subjects receiving metoclopramide nasal spray versus subjects receiving placebo.\n\nThe mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).\n\n1. Nausea (feeling sick to your stomach as if you were going to vomit or throw up)\n2. Early satiety (not able to finish a normal sized meal)\n3. Bloating (feeling like you need to loosen clothes)\n4. Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.\n\nA mean change (improvement) of \\>1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastroparesis', 'Diabetic Gastroparesis', 'Diabetes', 'Diabetes Mellitus', 'Delayed Gastric Emptying'], 'conditions': ['Gastroparesis', 'Diabetic Gastroparesis', 'Diabetes', 'Diabetes Mellitus', 'Delayed Gastric Emptying']}, 'referencesModule': {'references': [{'pmid': '25576687', 'type': 'DERIVED', 'citation': 'Parkman HP, Carlson MR, Gonyer D. Metoclopramide Nasal Spray Reduces Symptoms of Gastroparesis in Women, but not Men, With Diabetes: Results of a Phase 2B Randomized Study. Clin Gastroenterol Hepatol. 2015 Jul;13(7):1256-1263.e1. doi: 10.1016/j.cgh.2014.12.030. Epub 2015 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic gastroparesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Male subjects and non-pregnant, non-lactating female subjects between the ages of 18 and 75 years (inclusive)\n2. Willing and able to give written informed consent to participate in the study\n3. Ability to read and understand English\n4. Diagnosis of Type 1 or Type 2 diabetes\n5. Diagnosis of diabetic gastroparesis previously documented\n6. A mean daily GCSI-DD score of ≥2 and ≤4 for the 7 days prior to the Randomization Visit (Visit 3, Day 0)\n7. Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from Screening through the last dose of study drug: hormonal (oral, implant, or injection) begun \\>30 days prior to screening, barrier (condom, diaphragm, or cervical cap with spermicide), intrauterine device (IUD), or vasectomized partner (6-months minimum)\n8. No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results (with the exception of lipid profile, glucose and hemoglobin A1c) during screening which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results\n9. Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all medications specified by the protocol for the duration of the study\n\nExclusion Criteria\n\n1. Gastric bypass and gastric banding, gastric pacemakers, post-surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility such as active gastric ulcer, active duodenal ulcer, active severe gastritis, gastric cancer, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, and untreated hypothyroidism\n2. A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia to metoclopramide or any comparable or similar product\n3. History of or physical findings suggestive of tardive dyskinesia\n4. Currently using and unwilling or unable to stop any medication known to be associated with tardive dyskinesia (See Study Reference Manual) prior to Washout (Visit 2)\n5. History of allergy to any of the ingredients in the study drug formulation; metoclopramide, citric acid, sodium citrate, benzalkonium chloride, EDTA, or sorbitol\n6. History of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease\n7. Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of enrollment\n8. History of other clinically significant renal, hepatic, neurologic, hematologic, oncologic, pulmonary, psychiatric, cardiovascular or infectious disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results\n9. Have renal dysfunction calculated as creatinine clearance (CrCl) \\< 40 mL/min at Screening (Visit 1)\n10. Have a hemoglobin A1c \\> 12.5% at Screening (Visit 1)\n11. Inability or unwillingness to stop using the following agents for 7 days during the Washout Period (Day -7 to Day -1) prior to Randomization (Visit 3, Day 0) and refrain from their use for the 4-week study period; oral and parenteral formulations of metoclopramide, domperidone, tricyclic antidepressants, macrolide antibiotics, prokinetic agents, cholinergic agents, agents with significant anticholinergic effects, narcotic analgesics, orally administered β agonists, spasmolytics, dopamine agonists, monoamine oxidase inhibitors, herbal supplements, fiber or bulking products, and laxatives\n12. Use of neurotoxins (e.g., botulinum type A or B) as a treatment for gastroparesis or delayed gastric emptying within 6 months of Screening (Visit 1)\n13. Clinically significant abnormal finding or a QTc interval \\>450 milliseconds (msec) on ECGs obtained at Screening (Visit 1) OR pre- or post-dose at Randomization (Visit 3)\n14. Inability or unwillingness to stop using medications associated with Torsades de Pointes or a prolonged QT interval for 30 days prior to the initial symptom assessment and refrain from their use for the 4-week study period (see Study Reference Manual)\n15. Female subjects who are trying to conceive, are pregnant, or are lactating\n16. Positive serum human chorionic gonadotropin (HCG) pregnancy test at Screening or a positive HCG urine test on Day 0 prior to administration of study drug for women of childbearing potential\n17. History of alcohol or drug abuse within the year prior to the Screening Visit, or current known evidence of substance dependence or abuse\n18. Participation in a clinical (investigational) trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit (Visit 1) with the exception of domperidone"}, 'identificationModule': {'nctId': 'NCT00845858', 'briefTitle': 'Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Evoke Pharma'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Dose-Ranging Clinical Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Subjects With Gastroparesis', 'orgStudyIdInfo': {'id': 'METO-IN-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metoclopramide Nasal Spray 10 mg', 'interventionNames': ['Drug: metoclopramide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metoclopramide Nasal Spray 14 mg', 'interventionNames': ['Drug: metoclopramide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Nasal Spray', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'metoclopramide', 'type': 'DRUG', 'otherNames': ['Reglan'], 'description': '30 minutes before meals and at bedtime for 4 weeks', 'armGroupLabels': ['Metoclopramide Nasal Spray 10 mg', 'Metoclopramide Nasal Spray 14 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '30 minutes before meals and at bedtime', 'armGroupLabels': ['Placebo Nasal Spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Digestive Specialists of the Southeast', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Associates', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Affiliated Research Center, Inc.', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Desert Sun Gastroenterology', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clopton Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72120', 'city': 'Sherwood', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Gastroenterology', 'geoPoint': {'lat': 34.81509, 'lon': -92.22432}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Robert M. Karns, MD, a Medical Corporation', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Long Beach Healthcare System', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Impact Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Prime-Care Clinical Research', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '91307', 'city': 'West Hills', 'state': 'California', 'country': 'United States', 'facility': 'Infosphere Clinical Research, Inc.', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'zip': '91361', 'city': 'Westlake Village', 'state': 'California', 'country': 'United States', 'facility': 'Westlake Medical Research', 'geoPoint': {'lat': 34.14584, 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