Evaluate Safety of Tramadol in the Management of Postoperative Pain Following Surgery

NCT03395808 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AVE-901-104
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the safety of IV tramadol managing post-operative pain following surgery.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Reported Adverse Events

  Up to 21 days

Study Arms (1)

AVE-901 50mg

OTHER

IV Tramadol

Drug: Tramadol

Interventions

Tramadol DRUG

IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses

AVE-901 50mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is male or female 18-75 years of age
• 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 contraption
• The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 24 hours after surgery
• The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.

You may not qualify if:

• The patient has used chronic opioid therapy, defined as \>= 20 MEQs of morphine per day \>=3 days out of 7 days over the past 4 weeks.
• The patient has a recent (within 2 years) and/or current history of alcohol, opiate or tranquilizer abuse or dependence.
• The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 (e.g., fluoxetine, paroxetine, amitriptyline, quinidine, ketoconazole, erythromycin, grapefruit juice) or inducers of CYP3A4 (e.g., carbamazepine, rifampin, St. John's Wort) and cannot go through a minimum washout period of 7 days prior to surgery.
• The patient has a history of epilepsy, is susceptible to seizures.
• The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase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, amphetamines).
• The patient has had a recent (within 6 months) cardiovascular event or clinically significant abnormal ECG finding at screening.
• The patient has a history of Long QT Syndrome or a relative with this condition.
• The patient has expressed suicidal ideation within the past 3 months 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 CPAP or other treatment.
• Female patient is pregnant and/or undergoing a pregnancy-related surgery, or breastfeeding.
• The patient has a history of cardiopulmonary, neurological or psychiatric condition that may confound the assessments of efficacy or safety.
• The patient has cirrhosis, moderate or severe hepatic impairment or an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \> 3X upper limit of normal (ULN) at Screening.
• The patient has severe renal impairment or a serum creatinine value of \> 2x upper limit of normal (ULN) at Screening.
• The patient has potassium, sodium, calcium or magnesium levels outside of the normal range at Screening.
• The patient has a hemoglobin level at screening which, in the judgment of the Investigator, is not suitable for participation in this study.

Sponsors & Collaborators

• Avenue Therapeutics, Inc.: lead

Study Sites (1)

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

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: Micheal Ryan, VP Clinical
• Organization: Avenue Therapeutics

mryan@avenuetx.com

781-652-4514

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 10, 2018
• Study Start: December 22, 2017
• Primary Completion: April 25, 2019
• Study Completion: May 6, 2019
• Last Updated: March 9, 2021
• Results First Posted: March 9, 2021

Record last verified: 2019-06

Locations

US (1)