Status:
COMPLETED
Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
Lead Sponsor:
Avenue Therapeutics, Inc.
Conditions:
Pain Management
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy
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 r...
Eligibility Criteria
Inclusion
- Key
- The patient is male or female 18-75 years of age undergoing unilateral first metatarsal bunionectomy surgery
- 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 contraception
- The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 72 hours after surgery.
- The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.
Exclusion
- Patient is not expected to receive a continuous infusion nerve block as described in the Post-Op anesthetic procedures protocol
- Patient is undergoing bilateral or revision bunionectomy surgery
- The patient has allergy or hypersensitivity (or is intolerant) to opioids or tramadol The patient has known physical dependence on opioids
- The patient has taken other prior/concurrent chronic medications that have not been at a stable dose for at least 2 weeks prior to screening
- The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 or inducers of CYP3A4
- The patient has taken monoamine oxidase (MAO) inhibitors, trazodone, or cyclobenzaprine within 14 days prior to surgery
- The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase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).
- The patient has a history of epilepsy, or is known to be susceptible to seizures
- The patient has a history of Long QT Syndrome or a relative with this condition
- The patient has expressed suicidal ideation 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 pharmacological or device intervention.
- Clinically significant abnormalities in the judgement of the Investigator
- The patient was administered an investigational product within 30 days prior to Screening.
- The patient has previously participated in a clinical study with AVE-901.
Key Trial Info
Start Date :
September 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2018
Estimated Enrollment :
409 Patients enrolled
Trial Details
Trial ID
NCT03290378
Start Date
September 19 2017
End Date
April 23 2018
Last Update
March 19 2020
Active Locations (5)
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1
Trovare Clinical Research
Bakersfield, California, United States, 93301
2
Lotus Clinical Research
Pasadena, California, United States, 91105
3
Cheseapeake Research Group, LLC
Pasadena, Maryland, United States, 21122
4
H.D. Research Corporation
Houston, Texas, United States, 77004