Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 postoperative pain after bunionectomy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 Oliceridine | Experimental |
| |
| Treatment 2 Oliceridine | Experimental |
| |
| Treatment 3 Oliceridine | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| 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 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Respiratory Safety Events Compared to Morphine. | 48 hours | |
| Duration of Respiratory Safety Events Compared to Morphine. | 48 hours | |
| Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Pre-Surgical Entry Criteria
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment 1 Oliceridine | Oliceridine 0.1 mg |
| FG001 | Treatment 2 Oliceridine | Oliceridine 0.35 mg |
| FG002 | Treatment 3 Oliceridine | Oliceridine 0.5 mg |
| FG003 | Placebo | Placebo |
| FG004 | Morphine | Morphine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo. | The analysis population reflects the number of patients treated with study medication. | Posted | Count of Participants | Participants | 48 hours |
|
Not provided
Not provided
Not provided
| 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Arscott | Trevena, Inc. | 6103548840 | karscott@trevena.com |
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Morphine | Drug |
|
Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS assessment is captured in the primary outcome measure. |
| 48 hours |
| Number of Patients With Treatment-related Adverse Events. | 48 hours |
| Anaheim |
| California |
| 92801 |
| United States |
| Research Site | Pasadena | California | 91105 | United States |
| Research Site | Pasadena | Maryland | 21122 | United States |
| Research Site | Austin | Texas | 78229 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Resarch Site | Salt Lake City | Utah | 84124 | United States |
| BG002 |
| Treatment 3 Oliceridine |
Oliceridine 0.5 mg |
| BG003 | Placebo | Placebo |
| BG004 | 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/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Placebo | Placebo |
| OG004 | Morphine | Morphine |
|
|
| Secondary | Number of Respiratory Safety Events Compared to Morphine. | The analysis population reflects the number of patients treated with study medication. | Posted | Number | Respiratory Safety Events | 48 hours |
|
|
|
| Secondary | Duration of Respiratory Safety Events Compared to Morphine. | The analysis population reflects the number of patients treated with study medication. | Posted | Mean | Standard Error | hours | 48 hours |
|
|
|
| Secondary | Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine. | Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS 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 | 48 hours |
|
|
|
| Secondary | Number of Patients With Treatment-related Adverse Events. | The analysis population reflects the number of patients treated with study medication. | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| 76 |
| 0 |
| 76 |
| 56 |
| 76 |
| EG001 | Treatment 2 Oliceridine | Oliceridine 0.35 mg | 0 | 79 | 0 | 79 | 68 | 79 |
| EG002 | Treatment 3 Oliceridine | Oliceridine 0.5 mg | 0 | 79 | 0 | 79 | 72 | 79 |
| EG003 | Placebo | Placebo | 0 | 79 | 0 | 79 | 54 | 79 |
| EG004 | Morphine | Morphine | 0 | 76 | 0 | 76 | 73 | 76 |
| Vomiting | Gastrointestinal disorders |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Somnolence | Nervous system disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Hot Flush | Vascular disorders |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Hyperhydrosis | Skin and subcutaneous tissue disorders |
|
| Sedation | Nervous system disorders |
|
| Anxiety | Psychiatric disorders |
|
| Oxygen Saturation Decreased | Investigations |
|
| Muscle Twitching | Musculoskeletal and connective tissue disorders |
|
| Pruritus Generalized | Skin and subcutaneous tissue disorders |
|
| Infusion Site Extravasation | General disorders |
|
| Chest Discomfort | General disorders |
|
Not provided
| 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 |