Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy

NCT03290378 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AVE-901-102
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• The Sum of Pain Intensity Differences (SPID) Through 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.

  48 hours post first dose

Study Arms (3)

AVE-901 50 mg

ACTIVE COMPARATOR

Drug: Tramadol

AVE-901 25 mg

ACTIVE COMPARATOR

Drug: Tramadol

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Tramadol DRUG

IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

AVE-901 25 mg; AVE-901 50 mg

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Avenue Therapeutics, Inc.: lead

Study Sites (5)

Trovare Clinical Research

Bakersfield, California, 93301, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Cheseapeake Research Group, LLC

Pasadena, Maryland, 21122, United States

Location

H.D. Research Corporation

Houston, Texas, 77004, United States

Location

Endeavor Clinical Trials, PA

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 32683644 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Results Point of Contact

• Title: VP of Clinical Operations and Program Management
• Organization: Avenue Therapeutics

mryan@avenuetx.com

781-652-4514

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: September 19, 2017
• Primary Completion: April 11, 2018
• Study Completion: April 23, 2018
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2019-09

Locations

US (5)