Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain Management

In brief

The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy

Key facts

Study ID

NCT03290378

Run by

Avenue Therapeutics, Inc.

People needed

409

Starts

2017-09-19

Expected to finish

2018-04-23

Last updated by the study team

2020-03-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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• The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase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.

Where it is running

• Trovare Clinical Research — Bakersfield, California, United States
• Lotus Clinical Research — Pasadena, California, United States
• Cheseapeake Research Group, LLC — Pasadena, Maryland, United States
• H.D. Research Corporation — Houston, Texas, United States
• Endeavor Clinical Trials, PA — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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