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| Name | Class |
|---|---|
| Lotus Clinical Research, LLC | OTHER |
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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 following abdominoplasty.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRV130 | Experimental |
| |
| Morphine | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRV130 | Drug | Rescue: Ibuprofen, oxycodone |
| |
| Morphine |
| Measure | Description | Time Frame |
|---|---|---|
| Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 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 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. | 24-hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pasadena | California | 91105 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Protocol v1-4 TRV130 0.1 mg | TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout. |
| FG001 | Protocol v1-4 Morphine | Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout. |
| FG002 | Protocol v1-4 Placebo | Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout. |
| FG003 | Protocol v5 TRV130 0.35 mg | TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout. |
| FG004 | Protocol v5 Morphine | Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout. |
| FG005 | Protocol v5 Placebo | Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Protocol v1-4 TRV130 0.1 mg | TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout. |
| BG001 | Protocol v1-4 Morphine | Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 24 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 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. | Posted | Mean | Standard Deviation | score on a scale | 24-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 | Protocol v1-4 TRV130 0.1 mg | TRV130 loading doses totaling 1.5 mg. TRV130 0.1 mg PCA with 6-min lockout. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Arscott | Trevena, Inc. | 6103548840 | karscott@trevena.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| 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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| Drug |
Rescue: Ibuprofen, oxycodone |
|
|
| Placebo | Drug | Rescue: Ibuprofen, oxycodone |
|
|
| 24-hours |
| Houston |
| Texas |
| 77024 |
| United States |
| BG002 | Protocol v1-4 Placebo | Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout. |
| BG003 | Protocol v5 TRV130 0.35 mg | TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout. |
| BG004 | Protocol v5 Morphine | Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout. |
| BG005 | Protocol v5 Placebo | Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout.
| OG002 | Protocol v5 TRV130 0.35 mg | TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout. |
| OG003 | Protocol v5 Placebo | Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout. |
|
|
| Secondary | Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine | 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. | Posted | Mean | Standard Deviation | score on a scale | 24-hours |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 26 |
| 39 |
| EG001 | Protocol v1-4 Morphine | Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout. | 0 | 42 | 0 | 42 | 39 | 42 |
| EG002 | Protocol v1-4 Placebo | Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout. | 0 | 19 | 0 | 19 | 8 | 19 |
| EG003 | Protocol v5 TRV130 0.35 mg | TRV130 loading doses totaling 1.5 mg. TRV130 0.35 mg PCA with 6-min lockout. | 0 | 39 | 0 | 39 | 32 | 39 |
| EG004 | Protocol v5 Morphine | Morphine loading doses totaling 4 mg. Morphine 1 mg PCA with 6-min lockout. | 0 | 41 | 1 | 41 | 39 | 41 |
| EG005 | Protocol v5 Placebo | Placebo (5% D5W) loading doses totaling 4 ml. Placebo 1 ml PCA with 6-min lockout. | 0 | 20 | 0 | 20 | 16 | 20 |
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Local Swelling | General disorders |
|
| Upper Respiratory Tract Infection | Infections and infestations |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Presyncope | Nervous system disorders |
|
| Sedation | Nervous system disorders |
|
| Somnolence | Nervous system disorders |
|
| Tension Headache | Nervous system disorders |
|
| Hypoventilation | Respiratory, thoracic and mediastinal disorders |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Pruritus Generalized | Skin and subcutaneous tissue disorders |
|
| Hypotension | Vascular disorders |
|
| Regurgitation | Gastrointestinal disorders |
|
| Infusion Site Discomfort | General disorders |
|
| Infusion Site Extravasation | General disorders |
|
| Infusion Site Inflammation | General disorders |
|
| Infusion Site Pain | General disorders |
|
| Postoperative Fever | Injury, poisoning and procedural complications |
|
| Electrocardiogram T-Wave Abnormal | Investigations |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders |
|
| Syncope | Nervous system disorders |
|
| Insomina | Psychiatric disorders |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Phlebitis | Vascular 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 |