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

NCT ID: NCT03395808

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-22
• Study Completion Date: 2019-05-06

Brief Summary

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

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.

Conditions

Pain Management

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

AVE-901 50mg

IV Tramadol

Group Type: OTHER

Tramadol

Intervention Type: DRUG

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

Interventions

Tramadol

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avenue Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lotus Clinical Research

Pasadena, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AVE-901-104

Identifier Type: -

Identifier Source: org_study_id