Tramadol Versus Placebo and Morphine in the Management of Post-Operative Pain Abdominoplasty
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ClinicalTrials.gov Identifier: NCT03774836 |
Recruitment Status :
Active, not recruiting
First Posted : December 13, 2018
Last Update Posted : May 9, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain Management | Drug: Tramadol Drug: Morphine Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 360 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Multicenter, Randomized, Double-Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion (AVE-901) Versus Placebo and Morphine in the Management of Postoperative Pain Following Abdominoplasty |
Actual Study Start Date : | December 14, 2018 |
Estimated Primary Completion Date : | May 30, 2019 |
Estimated Study Completion Date : | June 30, 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Tramadol 50 mg
Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
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Drug: Tramadol
IV Tramadol 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
Active Comparator: Morphine 4 mg
Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
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Drug: Morphine
Morphine 4 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
Placebo Comparator: Placebo
Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
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Other: Placebo
Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
- The Sum of Pain Intensity Differences through 24 hours [ Time Frame: 24 hours post dose ]

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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 48 hours after surgery
- The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.
Exclusion Criteria:
- 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.

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): NCT03774836
United States, California | |
Lotus Clinical Research | |
Pasadena, California, United States, 91105 | |
United States, Texas | |
Hermann Drive Research | |
Houston, Texas, United States, 77004 | |
Endeavor Clinical Trials | |
San Antonio, Texas, United States, 78229 |
Responsible Party: | Avenue Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03774836 |
Other Study ID Numbers: |
AVE-901-103 |
First Posted: | December 13, 2018 Key Record Dates |
Last Update Posted: | May 9, 2019 |
Last Verified: | February 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Morphine Tramadol Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |