Evaluate Safety of Tramadol in the Management of Postoperative Pain Following Surgery
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ClinicalTrials.gov Identifier: NCT03395808 |
Recruitment Status :
Completed
First Posted : January 10, 2018
Results First Posted : March 9, 2021
Last Update Posted : March 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain Management | Drug: Tramadol | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 251 participants |
Allocation: | N/A |
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 |
Actual Primary Completion Date : | April 25, 2019 |
Actual Study Completion Date : | May 6, 2019 |

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 |
- Adverse Events [ Time Frame: Up to 21 days ]Reported Adverse Events

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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 |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395808
United States, California | |
Lotus Clinical Research | |
Pasadena, California, United States, 91105 |
Documents provided by Avenue Therapeutics, Inc.:
Responsible Party: | Avenue Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03395808 |
Other Study ID Numbers: |
AVE-901-104 |
First Posted: | January 10, 2018 Key Record Dates |
Results First Posted: | March 9, 2021 |
Last Update Posted: | March 9, 2021 |
Last Verified: | June 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Tramadol Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |