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The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute pain after abdominoplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 Oliceridine | Experimental |
| |
| Treatment 2 Oliceridine | Experimental |
| |
| Treatment 3 Oliceridine | Experimental |
| |
| Treatment 4 Placebo | Placebo Comparator |
| |
| Treatment 5 Morphine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oliceridine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. | The NPRS is an 11-point scale from 0-10 where "0" = no pain and "10" = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Respiratory Safety Events Compared to Morphine. | Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status. | 24 hours |
| Duration of Respiratory Events Compared to Morphine. |
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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 |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85027 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31162798 | Derived | Singla NK, Skobieranda F, Soergel DG, Salamea M, Burt DA, Demitrack MA, Viscusi ER. APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the mu-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty. Pain Pract. 2019 Sep;19(7):715-731. doi: 10.1111/papr.12801. Epub 2019 Jun 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment 1 Oliceridine | Oliceridine 0.1 mg The loading dose was 1.5 mg with PCA demand doses of 0.1 mg. Supplemental doses of 0.75 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens. |
| FG001 | Treatment 2 Oliceridine | Oliceridine 0.35 mg The loading dose was 1.5 mg with PCA demand doses of 0.35 mg. Supplemental doses of 0.75 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens. |
| FG002 | Treatment 3 Oliceridine | Oliceridine 0.5 mg The loading dose was 1.5 mg with PCA demand doses of 0.5 mg. Supplemental doses of 0.75 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens. |
| FG003 | Treatment 4 Placebo | Placebo The loading dose was 1.5 mL with volume-matched PCA demand doses. Supplemental doses of 0.75 mL were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens. |
| FG004 | Treatment 5 Morphine | Morphine The loading dose for the morphine treatment regimen was 4 mg with 1 mg demand doses. Supplemental doses of 2 mg were permitted, beginning 1 hour after the loading dose, and hourly thereafter, as needed. A lockout interval of 6 minutes was used for all PCA regimens. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment 1 Oliceridine | Oliceridine 0.1 mg |
| BG001 | Treatment 2 Oliceridine | Oliceridine 0.35 mg |
| 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 | Number of Patients Who Respond to Study Medication at the 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. | The NPRS is an 11-point scale from 0-10 where "0" = no pain and "10" = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit. | The analysis population reflects the number of patients treated with study medication. | Posted | Count of Participants | Participants | 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 | Treatment 1 Oliceridine | Oliceridine 0.1 mg | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Wall Hematoma | Gastrointestinal disorders |
| 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 |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Drug |
|
| Morphine | Drug |
|
Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status.
| 24 hours |
| Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine. | Odds ratio of 24-hour responder analysis versus morphine. Number of patients who responded to study medication at the 24-hr NPRS assessment is captured in the primary outcome measure. | 24 hours |
| Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine. | 24 hours |
| Pasadena |
| California |
| 91105 |
| United States |
| Research Site | Pasadena | Maryland | 21122 | United States |
| Research Site | Houston | Texas | 77027 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| BG002 |
| Treatment 3 Oliceridine |
Oliceridine 0.5 mg |
| BG003 | Treatment 4 Placebo | Placebo |
| BG004 | Treatment 5 Morphine | Morphine |
| BG005 | 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 |
|
| Treatment 2 Oliceridine |
Oliceridine 0.35 mg |
| OG002 | Treatment 3 Oliceridine | Oliceridine 0.5 mg |
| OG003 | Treatment 4 Placebo | Placebo |
| OG004 | Treatment 5 Morphine | Morphine |
|
|
| Secondary | Number of Respiratory Safety Events Compared to Morphine. | Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status. | The analysis population reflects the number of patients treated with study medication. | Posted | Number | Respiratory Safety Events | 24 hours |
|
|
|
| Secondary | Duration of Respiratory Events Compared to Morphine. | Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status. | The analysis population reflects the number of patients treated with study medication. | Posted | Mean | Standard Error | hours | 24 hours |
|
|
|
| Secondary | Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine. | Odds ratio of 24-hour responder analysis versus morphine. Number of patients who responded to study medication at the 24-hr NPRS assessment is captured in the primary outcome measure. | The analysis population reflects the number of patients treated with study medication. The morphine and placebo Arms/Groups are not included, as this is a comparison of study medication against morphine. | Posted | Number | odds ratio | 24 hours |
|
|
|
| Secondary | Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| 77 |
| 0 |
| 77 |
| 69 |
| 77 |
| EG001 | Treatment 2 Oliceridine | Oliceridine 0.35 mg | 0 | 80 | 1 | 80 | 74 | 80 |
| EG002 | Treatment 3 Oliceridine | Oliceridine 0.5 mg | 0 | 80 | 3 | 80 | 76 | 80 |
| EG003 | Treatment 4 Placebo | Placebo | 0 | 81 | 0 | 81 | 65 | 81 |
| EG004 | Treatment 5 Morphine | Morphine | 0 | 83 | 1 | 83 | 80 | 83 |
| Post Procedural Hemorrhage | Injury, poisoning and procedural complications |
|
| Lethargy | Nervous system disorders |
|
| Syncope | Nervous system disorders |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Headache | Nervous system disorders |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Dizziness | Nervous system disorders |
|
| Sedation | Nervous system disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Hot Flash | Vascular disorders |
|
| Anxiety | Psychiatric disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Restlessness | Psychiatric disorders |
|
| Hyperhydrosis | Skin and subcutaneous tissue disorders |
|
| Pruritus Generalized | Skin and subcutaneous tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Abdominal Pain Upper | Gastrointestinal disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Presyncope | Nervous system disorders |
|
| Somnolence | Nervous system 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 |