Tramadol Versus Placebo and Morphine in the Management of Post-Operative Pain Abdominoplasty

NCT03774836 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: AVE-901-103
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

Brief Summary

This study is evaluating the analgesic efficacy of intravenous (IV) tramadol (AVE-901) compared to placebo in the management of postoperative pain following abdominal surgery.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• The Sum of Pain Intensity Differences through 24 hours

  24 hours post dose

Study Arms (3)

Tramadol 50 mg

ACTIVE COMPARATOR

Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Drug: Tramadol

Morphine 4 mg

ACTIVE COMPARATOR

Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Drug: Morphine

Placebo

PLACEBO COMPARATOR

Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Other: Placebo

Interventions

Tramadol DRUG

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

Tramadol 50 mg

Morphine DRUG

Morphine 4 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Morphine 4 mg

Placebo OTHER

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: 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 48 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 is undergoing an abdominoplasty of significant complexity defined as pre-planned surgical time of greater than 180 mins.
• The patient has a recent (within 5 years) and/or current history of chronic analgesic, opiate or tranquilizer abuse or dependence or is a user of illicit drugs or has had a recent history (within 2 years) of drug or alcohol abuse.
• 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 14 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, cyclobenzaprine triptans).
• The patient has had a recent cardiovascular event or clinically significant abnormal ECG finding at screening or baseline.
• 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 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 or other medical 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 \> 2.0 mg/dL at Screening.
• The patient has potassium, sodium, calcium or magnesium levels outside of the normal range or any other clinically significant abnormalities in laboratory values at Screening.

Sponsors & Collaborators

• Avenue Therapeutics, Inc.: lead

Study Sites (3)

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Hermann Drive Research

Houston, Texas, 77004, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Tramadol; Morphine

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; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

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: December 11, 2018
• First Posted: December 13, 2018
• Study Start: December 14, 2018
• Primary Completion: May 30, 2019
• Study Completion: June 30, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-02

Locations

US (3)