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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.

Tracking Information
First Submitted Date  ICMJE September 19, 2017
First Posted Date  ICMJE September 21, 2017
Results First Submitted Date  ICMJE May 10, 2019
Results First Posted Date  ICMJE March 19, 2020
Last Update Posted Date March 19, 2020
Actual Study Start Date  ICMJE September 19, 2017
Actual Primary Completion Date April 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
The Sum of Pain Intensity Differences (SPID) through 48 hours post first dose [ Time Frame: 48 hours post first dose ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
Official Title  ICMJE 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
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 results in a number of enantiomeric metabolites that display different opioid-receptor binding properties, and monoaminergic reuptake inhibition.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain Management
Intervention  ICMJE
  • 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
  • Other: Placebo
    IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
Study Arms  ICMJE
  • Active Comparator: AVE-901 50 mg
    Intervention: Drug: Tramadol
  • Active Comparator: AVE-901 25 mg
    Intervention: Drug: Tramadol
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Singla NK, Pollak R, Gottlieb I, Leiman D, Minkowitz H, Zimmerman J, Harnett M, Ryan M, Lu L, Reines S. Efficacy and Safety of Intravenously Administered Tramadol in Patients with Moderate to Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study. Pain Ther. 2020 Dec;9(2):545-562. doi: 10.1007/s40122-020-00184-2. Epub 2020 Jul 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2017)
Actual Study Completion Date  ICMJE April 23, 2018
Actual Primary Completion Date April 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03290378
Other Study ID Numbers  ICMJE AVE-901-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Avenue Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Avenue Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Avenue Therapeutics, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP