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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005628-41 | 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 50 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nalbuphine HCl ER | Experimental | nalbuphine HCl ER |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nalbuphine HCl ER | Drug | nalbuphine HCl ER BID for up to 50 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) | Incidence of adverse events is calculated based on events observed on or after the date of first dose, where incidence is defined as the number of subjects who reported one or more events of a particular adverse event divided by the number of subjects who received at least one dose of investigational product. Overall incidence is the proportion of subjects who had one or more adverse events of any type and nature pertains to the incidence of individual events coded by MedDRA nomenclature. An additional consideration was to evaluate incidence of adverse events by dose achieved but this was not done as subjects achieved a maximum dose during the study that varied and, per protocol, dosing could be modified per the investigator, during the course of this extension to TR03. In addition, TR03EXT involved a dose titration whereas events could have been reported well before a subject achieved some partciular dose level. Consequently, such a presentation would have been impossible to discern. | 50 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 |
|---|---|---|---|---|---|---|
| University of Münster | Münster | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nalbuphine HCl ER | nalbuphine HCl ER nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nalbuphine HCl ER | nalbuphine HCl ER nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) | Incidence of adverse events is calculated based on events observed on or after the date of first dose, where incidence is defined as the number of subjects who reported one or more events of a particular adverse event divided by the number of subjects who received at least one dose of investigational product. Overall incidence is the proportion of subjects who had one or more adverse events of any type and nature pertains to the incidence of individual events coded by MedDRA nomenclature. An additional consideration was to evaluate incidence of adverse events by dose achieved but this was not done as subjects achieved a maximum dose during the study that varied and, per protocol, dosing could be modified per the investigator, during the course of this extension to TR03. In addition, TR03EXT involved a dose titration whereas events could have been reported well before a subject achieved some partciular dose level. Consequently, such a presentation would have been impossible to discern. | Posted | Count of Participants | Participants | 50 weeks |
|
Adverse events collected beginning with the first date and time of dosing through up to 50 weeks of dosing.
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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 nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Sciascia, MD | Trevi Therapeutics | 203-304-2499 | thomas.sciascia@trevitherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2016 | Aug 6, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2017 | Aug 6, 2020 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D011536 | Prurigo |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG000 |
| Nalbuphine HCl ER |
nalbuphine HCl ER nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks |
|
|
| 0 |
| 36 |
| 2 |
| 36 |
| 0 |
| 36 |
| Joint injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ulnocarpal abutment syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |