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The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRV130 1 mg | Experimental | TRV130 1 mg IV Q4H x 48 h |
|
| TRV130 2 mg | Experimental | TRV130 2 mg IV Q4H x 48 h |
|
| TRV130 3 mg | Experimental | TRV130 3 mg IV Q4H x 48 h |
|
| TRV130 4 mg | Experimental | TRV130 4 mg IV Q4H x 48 h |
|
| Morphine | Active Comparator | Morphine 4 mg IV Q4H x 48 h |
|
| Placebo | Placebo Comparator | Placebo (D5W) IV Q4H x 48 h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRV130 | Drug | TRV130 1 - 4 mg will be administered every 4 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | 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 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franck Skobieranda, MD | Trevena Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Research | Phoenix | Arizona | 85027 | United States | ||
| Chesapeake Research Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A - TRV130 1 mg | TRV130 1 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours |
| FG001 | Part A - TRV130 2 mg | TRV130 2 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours |
| FG002 | Part A - TRV130 3 mg | TRV130 3 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours |
| FG003 | Part A - TRV130 4 mg | TRV130 4 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours |
| FG004 | Part A - Morphine | Morphine 4 mg IV Q4H x 48 h Morphine: Morphine 4 mg will be administered every 4 hours |
| FG005 | Part A - Placebo | Placebo (D5W) IV Q4H x 48 h Placebo: Placebo will be administered every 4 hours |
| FG006 | Part B - TRV130 0.5 mg | TRV130 0.5 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| FG007 | Part B - TRV130 1 mg | TRV130 1 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| FG008 | Part B - TRV130 2 mg | TRV130 2 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| FG009 | Part B - TRV130 3 mg | TRV130 3 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| FG010 | Part B - Placebo | Placebo (D5W) IV Q3H x 48 h Placebo: Placebo will be administered every 3 hours |
| FG011 | Part B - Morphine | Morphine 4 mg IV Q4H x 48 h Morphine: Morphine 4 mg will be administered every 4 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A - TRV130 1 mg | TRV130 1 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours |
| BG001 | Part A - TRV130 2 mg | TRV130 2 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours |
| 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 | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo | 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 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS. | Posted | Mean | Standard Deviation | score on a scale | 48 hours |
|
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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 | Part A - TRV130 1 mg | TRV130 1 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Arscott | Trevena, Inc. | 6103548840 | karscott@trevena.com |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C586842 | ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine |
| D009020 | Morphine |
| D005947 | Glucose |
| D014867 | Water |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Morphine | Drug | Morphine 4 mg will be administered every 4 hours |
|
|
| Placebo | Drug | Placebo will be administered every 4 hours |
|
|
| Pasadena |
| Maryland |
| 21122 |
| United States |
| Premier Research | Austin | Texas | 78705 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| BG002 | Part A - TRV130 3 mg | TRV130 3 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours |
| BG003 | Part A - TRV130 4 mg | TRV130 4 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours |
| BG004 | Part A - Morphine | Morphine 4 mg IV Q4H x 48 h Morphine: Morphine 4 mg will be administered every 4 hours |
| BG005 | Part A - Placebo | Placebo (D5W) IV Q4H x 48 h Placebo: Placebo will be administered every 4 hours |
| BG006 | Part B - TRV130 0.5 mg | TRV130 0.5 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| BG007 | Part B - TRV130 1 mg | TRV130 1 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| BG008 | Part B - TRV130 2 mg | TRV130 2 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| BG009 | Part B - TRV130 3 mg | TRV130 3 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| BG010 | Part B - Placebo | Placebo (D5W) IV Q3H x 48 h Placebo: Placebo will be administered every 3 hours |
| BG011 | Part B - Morphine | Morphine 4 mg IV Q4H x 48 h Morphine: Morphine 4 mg will be administered every 4 hours |
| BG012 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
TRV130 2 mg IV Q4H x 48 h
TRV130: TRV130 1 - 4 mg will be administered every 4 hours
| OG002 | Part A - TRV130 3 mg | TRV130 3 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours |
| OG003 | Part A - TRV130 4 mg | TRV130 4 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours |
| OG004 | Part A - Morphine | Morphine 4 mg IV Q4H x 48 h Morphine: Morphine 4 mg will be administered every 4 hours |
| OG005 | Part A - Placebo | Placebo (D5W) IV Q4H x 48 h Placebo: Placebo will be administered every 4 hours |
| OG006 | Part B - TRV130 0.5 mg | TRV130 0.5 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| OG007 | Part B - TRV130 1 mg | TRV130 1 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| OG008 | Part B - TRV130 2 mg | TRV130 2 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| OG009 | Part B - TRV130 3 mg | TRV130 3 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours |
| OG010 | Part B - Placebo | Placebo (D5W) IV Q3H x 48 h Placebo: Placebo will be administered every 3 hours |
| OG011 | Part B - Morphine | Morphine 4 mg IV Q4H x 48 h Morphine: Morphine 4 mg will be administered every 4 hours |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 22 |
| 25 |
| EG001 | Part A - TRV130 2 mg | TRV130 2 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours | 0 | 24 | 0 | 24 | 21 | 24 |
| EG002 | Part A - TRV130 3 mg | TRV130 3 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours | 0 | 22 | 0 | 22 | 20 | 22 |
| EG003 | Part A - TRV130 4 mg | TRV130 4 mg IV Q4H x 48 h TRV130: TRV130 1 - 4 mg will be administered every 4 hours | 0 | 22 | 0 | 22 | 22 | 22 |
| EG004 | Part A - Morphine | Morphine 4 mg IV Q4H x 48 h Morphine: Morphine 4 mg will be administered every 4 hours | 0 | 25 | 0 | 25 | 23 | 25 |
| EG005 | Part A - Placebo | Placebo (D5W) IV Q4H x 48 h Placebo: Placebo will be administered every 4 hours | 0 | 23 | 0 | 23 | 11 | 23 |
| EG006 | Part B - TRV130 0.5 mg | TRV130 0.5 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours | 0 | 20 | 0 | 20 | 16 | 20 |
| EG007 | Part B - TRV130 1 mg | TRV130 1 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours | 0 | 38 | 0 | 38 | 31 | 38 |
| EG008 | Part B - TRV130 2 mg | TRV130 2 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours | 0 | 36 | 0 | 36 | 31 | 36 |
| EG009 | Part B - TRV130 3 mg | TRV130 3 mg IV Q3H x 48 h TRV130: TRV130 0.5 - 4 mg will be administered every 3 hours | 0 | 31 | 0 | 31 | 28 | 31 |
| EG010 | Part B - Placebo | Placebo (D5W) IV Q3H x 48 h Placebo: Placebo will be administered every 3 hours | 0 | 28 | 0 | 28 | 20 | 28 |
| EG011 | Part B - Morphine | Morphine 4 mg IV Q4H x 48 h Morphine: Morphine 4 mg will be administered every 4 hours | 0 | 39 | 0 | 39 | 31 | 39 |
| Dizziness | Nervous system disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Headache | Nervous system disorders |
|
| Somnolence | Nervous system disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Hot Flash | Vascular disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Hyperhydrosis | Skin and subcutaneous tissue disorders |
|
| Flushing | Vascular disorders |
|
| Paraesthesia | Nervous system disorders |
|
| Decreased Appetite | Metabolism and nutrition disorders |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders |
|
| Feeling Hot | General disorders |
|
| Pruritus Generalized | Skin and subcutaneous tissue disorders |
|
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| 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 |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |