Pain Management
Conditions
Brief summary
The study evaluates the safety of IV tramadol managing post-operative pain following surgery.
Detailed description
(Non-clinical summary) Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioidlike effects. Tramadol is extensively metabolized following administration, which results in a number of enantiomeric metabolites that display different opioid-receptor binding properties, and monoaminergic reuptake inhibition.
Interventions
DRUGTramadol
IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses
Sponsors
Avenue Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* The patient is male or female 18-75 years of age * Willing to give consent and able to understand the study procedures * Female patients must be of non-childbearing potential or be practicing a highly effective contraption * The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 24 hours after surgery * The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.
Exclusion criteria
* The patient has used chronic opioid therapy, defined as \>= 20 MEQs of morphine per day \>=3 days out of 7 days over the past 4 weeks. * The patient has a recent (within 2 years) and/or current history of alcohol, opiate or tranquilizer abuse or dependence. * The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 (e.g., fluoxetine, paroxetine, amitriptyline, quinidine, ketoconazole, erythromycin, grapefruit juice) or inducers of CYP3A4 (e.g., carbamazepine, rifampin, St. John's Wort) and cannot go through a minimum washout period of 7 days prior to surgery. * The patient has a history of epilepsy, is susceptible to seizures. * The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase serotonergic tone (e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, triptans, amphetamines). * The patient has had a recent (within 6 months) cardiovascular event or clinically significant abnormal ECG finding at screening. * The patient has a history of Long QT Syndrome or a relative with this condition. * The patient has expressed suicidal ideation within the past 3 months or is considered to be at risk of suicide. * The patient is morbidly obese (body mass index \[BMI\] ≥ 40 kg/m2) or has documented sleep apnea requiring CPAP or other treatment. * Female patient is pregnant and/or undergoing a pregnancy-related surgery, or breastfeeding. * The patient has a history of cardiopulmonary, neurological or psychiatric condition that may confound the assessments of efficacy or safety. * The patient has cirrhosis, moderate or severe hepatic impairment or an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \> 3X upper limit of normal (ULN) at Screening. * The patient has severe renal impairment or a serum creatinine value of \> 2x upper limit of normal (ULN) at Screening. * The patient has potassium, sodium, calcium or magnesium levels outside of the normal range at Screening. * The patient has a hemoglobin level at screening which, in the judgment of the Investigator, is not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to 21 days | Reported Adverse Events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AVE-901 50mg IV Tramadol
Tramadol: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses | 251 |
| Total | 251 |
Baseline characteristics
| Characteristic | AVE-901 50mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 50 Participants |
| Age, Categorical Between 18 and 65 years | 201 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 85 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 166 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 203 Participants |
| Region of Enrollment United States | 251 participants |
| Sex: Female, Male Female | 151 Participants |
| Sex: Female, Male Male | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 251 |
| other Total, other adverse events | 149 / 251 |
| serious Total, serious adverse events | 2 / 251 |
Outcome results
Primary
Adverse Events
Reported Adverse Events
Time frame: Up to 21 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Tramadol 50 mg | Adverse Events | 251 Participants |