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

• Sponsor: Avenue Therapeutics, Inc.
• Information provided by (Responsible Party): Avenue Therapeutics, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pain Management	Drug: Tramadol	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	250 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	A Phase 3, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety of Tramadol Infusion (AVE-901) in the Management of Post-Operative Pain Following Surgery
Actual Study Start Date :	December 22, 2017
Estimated Primary Completion Date :	June 30, 2019
Estimated Study Completion Date :	June 30, 2019

Arms and Interventions

Arm	Intervention/treatment
AVE-901 50mg; IV Tramadol	Drug: Tramadol; IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses

Outcome Measures

Primary Outcome Measures :

1. Adverse events [ Time Frame: Up to 21 days ]
   Reported Adverse Events
2. Local tolerability of the infusion site [ Time Frame: Up to 168 hours ]
   Infusion site reported Adverse Events

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Locations

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United States, California
Lotus Clinical Research
Pasadena, California, United States, 91105

Sponsors and Collaborators

Avenue Therapeutics, Inc.

More Information

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Responsible Party:	Avenue Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT03395808 History of Changes
Other Study ID Numbers:	AVE-901-104
First Posted:	January 10, 2018
Last Update Posted:	May 9, 2019
Last Verified:	May 2019

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Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

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Tramadol; Analgesics, Opioid; Narcotics; Central Nervous System Depressants	Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents