Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-31 @ 2:12 PM
Study NCT ID:
NCT02335294
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2015-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of TRV130 for the Treatment of Pain After Abdominoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C586842', 'term': '((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine'}, {'id': 'D009020', 'term': 'Morphine'}, {'id': 'D005947', 'term': 'Glucose'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karscott@trevena.com', 'phone': '6103548840', 'title': 'Kelly Arscott', 'organization': 'Trevena, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Protocol v1-4 TRV130 0.1 mg', 'description': 'TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 26, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Protocol v1-4 Morphine', 'description': 'Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 39, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Protocol v1-4 Placebo', 'description': 'Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 8, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Protocol v5 TRV130 0.35 mg', 'description': 'TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 32, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Protocol v5 Morphine', 'description': 'Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 39, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Protocol v5 Placebo', 'description': 'Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Local Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Tension Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypoventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pruritus Generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Infusion Site Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Infusion Site Extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Infusion Site Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Infusion Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Postoperative Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Electrocardiogram T-Wave Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Insomina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Protocol v1-4 TRV130 0.1 mg', 'description': 'TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.'}, {'id': 'OG001', 'title': 'Protocol v1-4 Placebo', 'description': 'Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.'}, {'id': 'OG002', 'title': 'Protocol v5 TRV130 0.35 mg', 'description': 'TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.'}, {'id': 'OG003', 'title': 'Protocol v5 Placebo', 'description': 'Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '2.32', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '2.93', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24-hours', 'description': 'Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Protocol v1-4 TRV130 0.1 mg', 'description': 'TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.'}, {'id': 'OG001', 'title': 'Protocol v1-4 Morphine', 'description': 'Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.'}, {'id': 'OG002', 'title': 'Protocol v5 TRV130 0.35 mg', 'description': 'TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.'}, {'id': 'OG003', 'title': 'Protocol v5 Morphine', 'description': 'Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '2.74', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '2.32', 'groupId': 'OG002'}, {'value': '-3.6', 'spread': '2.61', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24-hours', 'description': 'Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Protocol v1-4 TRV130 0.1 mg', 'description': 'TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.'}, {'id': 'FG001', 'title': 'Protocol v1-4 Morphine', 'description': 'Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.'}, {'id': 'FG002', 'title': 'Protocol v1-4 Placebo', 'description': 'Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.'}, {'id': 'FG003', 'title': 'Protocol v5 TRV130 0.35 mg', 'description': 'TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.'}, {'id': 'FG004', 'title': 'Protocol v5 Morphine', 'description': 'Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.'}, {'id': 'FG005', 'title': 'Protocol v5 Placebo', 'description': 'Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '39'}, {'groupId': 'FG005', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '200', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Protocol v1-4 TRV130 0.1 mg', 'description': 'TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout.'}, {'id': 'BG001', 'title': 'Protocol v1-4 Morphine', 'description': 'Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.'}, {'id': 'BG002', 'title': 'Protocol v1-4 Placebo', 'description': 'Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.'}, {'id': 'BG003', 'title': 'Protocol v5 TRV130 0.35 mg', 'description': 'TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout.'}, {'id': 'BG004', 'title': 'Protocol v5 Morphine', 'description': 'Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout.'}, {'id': 'BG005', 'title': 'Protocol v5 Placebo', 'description': 'Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.'}, {'id': 'BG006', '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '200', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '8.07', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '9.23', 'groupId': 'BG001'}, {'value': '36.6', 'spread': '8.60', 'groupId': 'BG002'}, {'value': '40.3', 'spread': '11.987', 'groupId': 'BG003'}, {'value': '38.4', 'spread': '9.064', 'groupId': 'BG004'}, {'value': '38.5', 'spread': '10.018', 'groupId': 'BG005'}, {'value': '38.2', 'spread': '9.57', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '198', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '129', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], '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': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '82', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '107', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '200', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, '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': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'dispFirstSubmitDate': '2017-09-15', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-11', 'studyFirstSubmitDate': '2015-01-07', 'dispFirstSubmitQcDate': '2018-07-23', 'resultsFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2015-01-08', 'dispFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-11', 'studyFirstPostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo', 'timeFrame': '24-hours', 'description': 'Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.'}], 'secondaryOutcomes': [{'measure': 'Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine', 'timeFrame': '24-hours', 'description': 'Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'abdominoplasty', 'PCA'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain following abdominoplasty.', 'detailedDescription': 'The primary objective is to evaluate the analgesic efficacy of intravenous (IV) TRV130 administered via patient controlled analgesia device (PCA) compared with placebo administered via PCA in patients with moderate to severe, acute postoperative pain following abdominoplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>=18 and \\<=65 years of age.\n* Plans to undergo an abdominoplasty procedure with no additional collateral procedures.\n* Is able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure.\n\nExclusion Criteria:\n\n* ASA Physical Status Classification System classification of P3 or worse.\n* Has surgical or post-surgical complications.\n* Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.\n* Has previously participated in another TRV130 clinical study.'}, 'identificationModule': {'nctId': 'NCT02335294', 'briefTitle': 'A Study of TRV130 for the Treatment of Pain After Abdominoplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Trevena Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain Following Abdominoplasty', 'orgStudyIdInfo': {'id': 'CP130-2002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRV130', 'interventionNames': ['Drug: TRV130']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine', 'interventionNames': ['Drug: Morphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TRV130', 'type': 'DRUG', 'description': 'Rescue: Ibuprofen, oxycodone', 'armGroupLabels': ['TRV130']}, {'name': 'Morphine', 'type': 'DRUG', 'otherNames': ['Morphine sulphate'], 'description': 'Rescue: Ibuprofen, oxycodone', 'armGroupLabels': ['Morphine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Dextrose 5% in water, D5W'], 'description': 'Rescue: Ibuprofen, oxycodone', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trevena Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Lotus Clinical Research, LLC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}