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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005626-29 | EudraCT Number |
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The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nalbuphine HCl ER | Experimental | nalbuphine HCl ER titrated from a dose of 30 mg QD to 120 BID for up to 3 weeks based on tolerability and efficacy, then maintained for an additional 21 weeks. Total duration of 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nalbuphine HCl ER | Drug | nalbuphine HCl ER |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) | The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence) | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Development Officer | Trevi Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Associates PC | Birmingham | Alabama | 35211 | United States | ||
| University South Alabama Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nalbuphine HCl ER | nalbuphine HCl ER nalbuphine HCl ER BID: nalbuphine HCl ER titrated from 30 mg QD to 120 mg BID over three weeks based on tolerability and efficacy, then maintain dosing at that maximum achieved level; full titration and maintenance is 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Mobile |
| Alabama |
| 36617 |
| United States |
| Arizona Kidney Disease and Hypertension Center | Phoenix | Arizona | 85012 | United States |
| U.S. Renal Care Inc. | Pine Bluff | Arkansas | 71603 | United States |
| North America Research Institute | Azusa | California | 91702 | United States |
| Pegasus Dialysis Center | Bakersfield | California | 93308 | United States |
| Central Nephrology Medical Group | Bakersfield | California | 93309 | United States |
| Mark Lee MD, Inc | Whittier | California | 90606 | United States |
| Nephrology and Hypertension Associates PC | Middlebury | Connecticut | 06762 | United States |
| Pines Clinical Research | Pembroke Pines | Florida | 33025 | United States |
| Genesis Clinical Research | Tampa | Florida | 33614 | United States |
| DaVita Central Orlando Dialysis | Winter Park | Florida | 32789 | United States |
| Southwest Georgia Nephrology Clinic PC | Albany | Georgia | 31701 | United States |
| Renal Physicians of Georgia | Macon | Georgia | 31217 | United States |
| Pacific Renal Research Institute | Meridian | Idaho | 83642 | United States |
| Fresenius Medical Care of Evergreen Park | Evergreen Park | Illinois | 60805 | United States |
| Western New England Renal and Transplant Association | Springfield | Massachusetts | 01107 | United States |
| Nephrology Center DBA Paragon Health | Kalamazoo | Michigan | 49007 | United States |
| McComb Limited Care Facility | McComb | Mississippi | 39648 | United States |
| Kidney Associates of Kansas City PC | Kansas City | Missouri | 64131 | United States |
| Nephrology-Hypertension Associates of Central New Jersey PA | North Brunswick | New Jersey | 80902 | United States |
| Renal Medicine Associates | Albuquerque | New Mexico | 87109 | United States |
| Newtown Dialysis Center Inc | Astoria | New York | 11102 | United States |
| Durham Nephrology Associates | Durham | North Carolina | 27704 | United States |
| Wake Nephrology Associates PA | Raleigh | North Carolina | 27609 | United States |
| Brookview Hills Research Associates LLC | Winston-Salem | North Carolina | 27103 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Nephrology Research Consortium | Bethlehem | Pennsylvania | 18017 | United States |
| Delaware Valley Nephrology | Philadelphia | Pennsylvania | 19118 | United States |
| Dialysis Clinic, Inc. | Philadelphia | Pennsylvania | 19140 | United States |
| Carolina Diabetes and Kidney Center | Sumter | South Carolina | 29150 | United States |
| SouthEast Renal Research Institute | Chattanooga | Tennessee | 37408 | United States |
| U.S. Renal Care, Inc. | Fort Worth | Texas | 76105 | United States |
| U.S. Renal Care Inc. | Fort Worth | Texas | 76164 | United States |
| U.S. Renal Care Inc | Mansfield | Texas | 76063 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nalbuphine HCl ER | nalbuphine HCl ER |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) | The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence) | Posted | Count of Participants | Participants | 24 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nalbuphine HCl ER | nalbuphine HCl ER | 0 | 167 | 54 | 167 | 0 | 167 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriovenous graft site infection | Infections and infestations |
| |||
| Sepsis | Infections and infestations |
| |||
| Diverticulitis | Infections and infestations |
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| Pneumonia | Infections and infestations |
| |||
| Septic shock | Infections and infestations |
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| Abcess neck | Infections and infestations |
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| Arthritis bacterial | Infections and infestations |
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| Bronchitis bacterial | Infections and infestations |
| |||
| Clostridium difficile infection | Infections and infestations |
| |||
| Cystitis | Infections and infestations |
| |||
| Endometritis | Infections and infestations |
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| Influenza | Infections and infestations |
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| Staphylococcal infection | Infections and infestations |
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| Urinary tract infection | Infections and infestations |
| |||
| Urospesis | Infections and infestations |
| |||
| Syncope | Nervous system disorders |
| |||
| Ataxia | Nervous system disorders |
| |||
| Cerebrovascular accident | Nervous system disorders |
| |||
| Convulsion | Nervous system disorders |
| |||
| Haemorrhagic stroke | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Presyncope | Nervous system disorders |
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| Speech disorder | Nervous system disorders |
| |||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders |
| |||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders |
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| Hypotension | Vascular disorders |
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| Hypertension | Vascular disorders |
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| Orthostatic hypotension | Vascular disorders |
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| Hypertensive emergency | Vascular disorders |
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| Jugular vein thrombosis | Vascular disorders |
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| Malignant hypertension | Vascular disorders |
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| Constipation | Gastrointestinal disorders |
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| Colitis | Gastrointestinal disorders |
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| Gastritis | Gastrointestinal disorders |
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| Gastrointestinal inflammation | Gastrointestinal disorders |
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| Pancreatitis | Gastrointestinal disorders |
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| Proctitis | Gastrointestinal disorders |
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| Retroperitoneal haematoma | Gastrointestinal disorders |
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| Umbilical hernia | Gastrointestinal disorders |
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| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications |
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| Arteriovenous graft site hemorrhage | Injury, poisoning and procedural complications |
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| Dialysis related complication | Injury, poisoning and procedural complications |
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| Femur fracture | Injury, poisoning and procedural complications |
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| Pelvic fracture | Injury, poisoning and procedural complications |
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| Tibia fracture | Injury, poisoning and procedural complications |
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| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications |
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| Vascular graft complication | Injury, poisoning and procedural complications |
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| Non-cardiac chest pain | General disorders |
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| Sudden cardiac death | General disorders |
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| Systemic inflammatory response syndrome | General disorders |
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| Cardiac arrest | Cardiac disorders |
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| Cardiac failure | Cardiac disorders |
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| Cardiac failure acute | Cardiac disorders |
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| Cardiac failure congestive | Cardiac disorders |
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| Myocardial infarction | Cardiac disorders |
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| Fluid overload | Metabolism and nutrition disorders |
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| Hypocalcaemia | Metabolism and nutrition disorders |
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| Hyperglycaemia | Metabolism and nutrition disorders |
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| Cholecystitis acute | Hepatobiliary disorders |
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| Cholangitis | Hepatobiliary disorders |
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| Cholelithiasis | Hepatobiliary disorders |
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| Anaemia | Blood and lymphatic system disorders |
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| Adrenal insufficiency | Endocrine disorders |
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| Anticoagulation drug level below therapeutic | Investigations |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Sciascia, MD | Trevi Therapeutics | 203-304-2499 | thomas.sciascia@trevitherapeutics.com |
| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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