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Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03290378
Recruitment Status : Completed
First Posted : September 21, 2017
Results First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Information provided by (Responsible Party):
Avenue Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Pain Management Drug: Tramadol Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 409 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion (AVE-901) Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
Actual Study Start Date : September 19, 2017
Actual Primary Completion Date : April 11, 2018
Actual Study Completion Date : April 23, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Active Comparator: AVE-901 50 mg Drug: Tramadol
IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Active Comparator: AVE-901 25 mg Drug: Tramadol
IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Placebo Comparator: Placebo Other: Placebo
IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Primary Outcome Measures :
  1. The Sum of Pain Intensity Differences (SPID) Through 48 Hours Post First Dose [ Time Frame: 48 hours post first dose ]
    Pain intensity was recorded using the Numerical Pain Rating Scale (NPRS) from 0 to 10, where 0 was no pain and 10 was the worst pain imaginable at hrs: .5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48. As higher pain scores indicate worse pain, a negative Pain Intensity Difference (PID) indicates less pain (improvement from baseline). Thus, SPID scores are expected to be negative if a patient's pain decreases over time, with the lower SPID values indicating greater reduction in pain intensity.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290378

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United States, California
Trovare Clinical Research
Bakersfield, California, United States, 93301
Lotus Clinical Research
Pasadena, California, United States, 91105
United States, Maryland
Cheseapeake Research Group, LLC
Pasadena, Maryland, United States, 21122
United States, Texas
H.D. Research Corporation
Houston, Texas, United States, 77004
Endeavor Clinical Trials, PA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Avenue Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Avenue Therapeutics, Inc.:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Avenue Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03290378    
Other Study ID Numbers: AVE-901-102
First Posted: September 21, 2017    Key Record Dates
Results First Posted: March 19, 2020
Last Update Posted: March 19, 2020
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents