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Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy

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ClinicalTrials.gov Identifier: NCT03290378
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Avenue Therapeutics, Inc.

Study Description
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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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 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
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The Sum of Pain Intensity Differences (SPID) through 48 hours post first dose [ Time Frame: 48 hours post first dose ]

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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


Contacts
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Contact: Michael Ryan, MS 781-652-4514 mryan@fortressbiotech.com
Contact: Amy Wheeler 781-652-4509 awheeler@fortressbiotech.com

Locations
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United States, California
Trovare Clinical Research Recruiting
Bakersfield, California, United States, 93301
Contact: John Zimmerman, DPM    661-663-3096      
Principal Investigator: John Zimmerman, DPM         
Lotus Clinical Research Recruiting
Pasadena, California, United States, 91105
Contact: Fardin Hakakian, DPM         
United States, Maryland
Cheseapeake Research Group, LLC Recruiting
Pasadena, Maryland, United States, 21122
Contact: Ira Gottlieb, DPM    410-761-0118      
United States, Texas
H.D. Research Corporation Recruiting
Houston, Texas, United States, 77004
Contact: David Leiman, MD    713-894-4840      
Endeavor Clinical Trials, PA Recruiting
San Antonio, Texas, United States, 78229
Contact: Richard Pollak, DPM    210-949-0807      
Sponsors and Collaborators
Avenue Therapeutics, Inc.
More Information
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Responsible Party: Avenue Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03290378     History of Changes
Other Study ID Numbers: AVE-901-102
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

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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
Pain
Neurologic Manifestations
Signs and Symptoms
Tramadol
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents